OSSIOfiber™ enables intelligent bone regeneration with nothing left behind. Nature works in magical ways and has the amazing ability to heal fractured bone. OSSIOfiber™ harnesses that power to reinforce and restore healthy bone using a strong, bio-integrative material, leaving the body renewed without permanent hardware.
Naturally Transformative Bone Healing
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Vast Surgical Applications
OSSIOfiber™ is a proprietary material platform aimed to provide the first credible replacement to permanent implants. As a first-of-its-kind implant material, OSSIOfiber™ is stronger than cortical bone and leaves nothing permanent behind. It combines the strength required for functional fixation with the ability to fully integrate into the native anatomy—without adverse inflammation.This technology has broad surgical applications through OSSIO’s ability to manufacture endless implant designs that utilize existing reimbursement and do not alter surgical techniques.
Utilizes Existing Reimbursement and Surgical Techniques
Bone In-Growth, Regeneration, and Replacement
Avoids Risks and Costs Associated with Permanent Implants
Strong, Secure Fixations
5 Critical Elements over other implant materials
OSSIOfiber™ Intelligent Bone Regeneration Technology
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INTRODUCTION
What makes OSSIOfiber™ unique?Proven materials engineered into a proprietary strong and bio-integrative matrix
50% Natural Mineral Fibers • Composed of silica, magnesium, calcium, and other natural
minerals found in bone• Mineral fibers have been in clinical use for over 30 years,
most commonly as osteoconductive bone void fillers
50% Polymer• Poly-L-D-lactide (PLDLA) binds the fiber matrix together • PLDLA has over 30 years of clinical success and can be gradually
and naturally cleared by the body through hydrolysis
Natural mineral fiber matrix suspended in the polymer
Scanning Electron Microscopy (SEM)of natural mineral fiber
suspended in the polymerSurface texture enables early bone attachment
OSSIOfiber’s reinforced bio-integrative material composition and structural design support both biomechanical performance and bone incorporation.
Balanced, favorable bone regeneration environment
Mineral fibers integrated and replaced by bone
Polymer cleared by hydrolysis (blue arrows)
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MATERIAL COMPONENTS
Proven materials engineered into a proprietary strong and bio-integrative matrix
–
Natural mineral fiber matrix suspended in the polymer
Scanning Electron Microscopy (SEM)of natural mineral fiber
suspended in the polymerSurface texture enables early bone attachment
Data on File at OSSIO.
The desired strength for insertion and secure fixationA high-performing matrix of reinforcing mineral fibers
OSSIOfiber™ sustains mechanical performance for bone fixation throughout the healing period of an osteotomy, fusion, or fracture.
24
Healing BoneGradual Integration and Load Sharing0
5,000
10,000
15,000
20,000
25,000
2 4 6 8 10 12 104
Stre
ngth
: Ela
stic
Mod
ulus
(MPa
)
Weeks Post Surgery
Strong, Fixation PhaseOSSIOfiber™
0
Conventional BioresorbablesPEEK Pre-injury
0Renewed Healthy BoneHealthy Cortical Bone Strength
RESTORE
Initial, secure fixation at the time of surgery1.5X strength above cortical bone for secure insertion and initial fixationUp to 2X strength compared to PEEKUp to 5X strength compared to conventional polymer bioresorbables
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STRENGTH
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24
Healing BoneGradual Integration and Load Sharing0
5,000
10,000
15,000
20,000
25,000
2 4 6 8 10 12 104
Stre
ngth
: Ela
stic
Mod
ulus
(MPa
)
Weeks Post Surgery
Strong, Fixation PhaseOSSIOfiber™
0
Conventional BioresorbablesPEEK Pre-injury
0Renewed Healthy BoneHealthy Cortical Bone Strength
Data on File at OSSIO.
The desired strength for insertion and secure fixationA high-performing matrix of reinforcing mineral fibers
REGROW
Healing and rehabilitation phase with sustained fixation strength and gradual bone integrationBetter match than metal to natural bone’s stiffness to aid in prevention of stress risersGradual bone integration within OSSIOfiber™ implants enables load sharing during healing and rehabilitation
OSSIOfiber™ sustains mechanical performance for bone fixation throughout the healing period of an osteotomy, fusion, or fracture.
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STRENGTH
Data on File at OSSIO.
The desired strength for insertion and secure fixationA high-performing matrix of reinforcing mineral fibers
24
Healing BoneGradual Integration and Load Sharing0
5,000
10,000
15,000
20,000
25,000
2 4 6 8 10 12 104
Stre
ngth
: Ela
stic
Mod
ulus
(MPa
)
Weeks Post Surgery
Strong, Fixation PhaseOSSIOfiber™
0
Conventional BioresorbablesPEEK Pre-injury
0Renewed Healthy BoneHealthy Cortical Bone Strength
RENEW
Only nature remainsPatient is healed with no permanent hardware left behind
OSSIOfiber™ sustains mechanical performance for bone fixation throughout the healing period of an osteotomy, fusion, or fracture.
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STRENGTH
INTRODUCTION
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STRENGTH OSSIOfiber™ sustains mechanical performance for bone fixation throughout the healing period of an osteotomy, fusion, or fracture.
24
Healing BoneGradual Integration and Load Sharing0
5,000
10,000
15,000
20,000
25,000
2 4 6 8 10 12 104
Stre
ngth
: Ela
stic
Mod
ulus
(MPa
)
Weeks Post Surgery
Strong, Fixation PhaseOSSIOfiber™
0
Conventional BioresorbablesPEEK Pre-injury
0Renewed Healthy BoneHealthy Cortical Bone Strength
–
OSSIOfiber™ Gradual and intelligent incorporation Polymer is virtually eliminated by 78 weeks
OSSIOfiber™
Early bone attachment and in-growth Gradual integration with surrounding anatomy with no adverse inflammation observed
OSSIOfiber™ fully integrated within 78-104 weeks
! No observed integration within 52 weeks! Fibrotic encapsulation and cracks in material observed! Severe, abrupt decline of polymer content from
78-104 weeks suggests local adverse inflammation due to burst effect, commonly observed within conventional polymer bioresorbables1-4
Pre-clinical Animal Study
vs Conventional Bioresorbable
In-bone implantation in rabbit femurs (weeks)
Polymer Incorporation Profile5
% o
f pol
ymer
rem
aini
ng
0%
25%
50%
75%
100%
0 10412 26 52 78
Conventional Bioresorbable
80%polymer
remaining
10-15%polymer remaining
Virtuallyeliminated
OSSIOfiber™
OSSIOfiber™
Fully integrated into surrounding bone within 78-104 weeks
ControlSevere, abrupt decline in polymer
content suggests burst effect
!
Incorporation Timeline
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BIO-INTEGRATIVE
In-bone implantation in rabbit femurs (weeks)
Polymer Incorporation Profile5
% o
f pol
ymer
rem
aini
ng
0%
25%
50%
75%
100%
0 10412 26 52 78
Conventional Bioresorbable
80%polymer
remaining
10-15%polymer remaining
Virtuallyeliminated
OSSIOfiber™
OSSIOfiber™
Fully integrated into surrounding bone within 78-104 weeks
ControlSevere, abrupt decline in polymer
content suggests burst effect
!
–
Bone in-growth, regeneration, and complete replacement Pre-clinical animal study5: OSSIOfiber™ Implant vs Conventional Bioresorbable Polymer Implant (Control) Proven in pre-clinical studies, OSSIOfiber™ integrates into the native anatomy without adverse inflammation, local osteolysis, cyst formation, or fibrotic encapsulation. Only nature remains in the bone.
OSSIOfiber™ Control (PLDLA)
0-13 WEEKS
2 weeks New trabecular bone forming and attaching
6 weeks Bone-forming cells penetrating implant surface and surrounding mineral fibers
13 weeks Bone and tissue in-growth continues with <75% polymer remaining
Cortical Bone
EARLY BONE ATTACHMENT AND IN-GROWTH NO OBSERVED INTEGRATION
Implant
Cortical Bone
13 weeks
Polymer Profile
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Pre-clinical animal study5: OSSIOfiber™ Implant vs Conventional Bioresorbable Polymer Implant (Control)
OSSIOfiber™ Control (PLDLA)
0-13 WEEKS
EARLY BONE ATTACHMENT AND IN-GROWTH NO OBSERVED INTEGRATION
2 weeks New trabecular bone forming and attaching
6 weeks Bone-forming cells penetrating implant surface and surrounding mineral fibers
13 weeks Bone and tissue in-growth continues with <75% polymer remaining
Cortical Bone
Implant
Cortical Bone
13 weeks
–
Pronounced new bone and tissue in-growth within implant
Implant
Implant remainsFibrotic encapsulation of implant
Medullary Fat
Medullary Fat
Bone in-growth, regeneration, and complete replacement Pre-clinical animal study5: OSSIOfiber™ Implant vs Conventional Bioresorbable Polymer Implant (Control) Proven in pre-clinical studies, OSSIOfiber™ integrates into the native anatomy without adverse inflammation, local osteolysis, cyst formation, or fibrotic encapsulation. Only nature remains in the bone.
GRADUAL BONE INTEGRATION NO BONE IN-GROWTH
OSSIOfiber™ Control (PLDLA)
26-52 WEEKS
Polymer Profile
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BIO-INTEGRATIVE
Pre-clinical animal study5: OSSIOfiber™ Implant vs Conventional Bioresorbable Polymer Implant (Control)
OSSIOfiber™ Control (PLDLA)
26-52 WEEKS
GRADUAL BONE INTEGRATION NO BONE IN-GROWTH
Pronounced new bone and tissue in-growth within implant
Implant
Implant remainsFibrotic encapsulation of implant
Medullary Fat
Medullary Fat
–
Bone in-growth, regeneration, and complete replacement Pre-clinical animal study5: OSSIOfiber™ Implant vs Conventional Bioresorbable Polymer Implant (Control) Proven in pre-clinical studies, OSSIOfiber™ integrates into the native anatomy without adverse inflammation, local osteolysis, cyst formation, or fibrotic encapsulation. Only nature remains in the bone.
ONLY NATURE REMAINS DELAYED BURST EFFECT
OSSIOfiber™ fully integrated into surrounding anatomy within 78-104 weeks
104 weeks Polymer eliminated and mineral fibers remodeled into bone
78 weeksHealthy cortical bone remodeled at implant site
104 weeks Presence of lymphocytes and macrophagesSevere, abrupt degradation in polymer content suggests local adverse inflammation due to burst effect
78 weeksCracks propagating throughout the implant>80% polymer remains
OSSIOfiber™ Control (PLDLA)
78-104 WEEKS
Polymer Profile
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BIO-INTEGRATIVE
Pre-clinical animal study5: OSSIOfiber™ Implant vs Conventional Bioresorbable Polymer Implant (Control)
OSSIOfiber™ Control (PLDLA)
78-104 WEEKS
ONLY NATURE REMAINS DELAYED BURST EFFECT
104 weeks Presence of lymphocytes and macrophagesSevere, abrupt degradation in polymer content suggests local adverse inflammation due to burst effect
78 weeksCracks propagating throughout the implant>80% polymer remains
OSSIOfiber™ fully integrated into surrounding anatomy within 78-104 weeks
104 weeks Polymer eliminated and mineral fibers remodeled into bone
78 weeksHealthy cortical bone remodeled at implant site
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Stro
ng
Mec
hani
cal p
erfo
rman
ce fo
r bon
e fix
atio
n
Natural Bone Regeneration Ability to fully integrate into native bone without adverse inflammation
PEEK
Bioresorbables
Bio-composites
New Category:Bio-Integrative Fixation
Metal
OSSIOfiber™
OSSIOfiber™: A breakthrough fixation material platform
The generations of trade-offs for
orthopedic fixation between strength and
bone regeneration have been solved.
Material Characteristics
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COMPETITIVE COMPARISON St
rong
M
echa
nica
l per
form
ance
for b
one
fixat
ion
Natural Bone Regeneration Ability to fully integrate into native bone without adverse inflammation
PEEK
Bioresorbables
Bio-composites
New Category:Bio-Integrative Fixation
Metal
OSSIOfiber™
–
Data on File at OSSIO.
StrongDesired strength for insertion and secure fixation
Bio-IntegrativeRapid bone regrowth, incorporation, and complete replacement without adverse complications
See how the characteristics of strong and bio-integrative OSSIOfiber™ compare to metal, PEEK, and bioresorbable materials.
Finally, an evolution for fixation materials that are strong and bio-integrative
Metal PEEK Bioresorbable Bio-Integrative
Eliminate risk of permanent hardware removal
Ability to incorporate into native bone in <2 years
Early bone attachment and in-growth
Strong fixation for load-bearing implants
Strength during insertion
Stiffness matched for cortical bone
Ability to drill through implant for
easier revision surgeries
Artifact-free CT and X-ray imaging, MRI safe
Non-permanent fixation
Platform Strengths
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OSSIOfiber™ Hammertoe Fixation System
Kit Ordering Information
Tactile feedback upon insertion with stopper
Opposing barbs to prevent pull-out and rotation
Data on File at OSSIO.
Convenient Disposable KitThe Strong and Bio-Integrative Implant
• Disposable K-Wire, Drill Bit, and Inserter provided
• Implants packaged with disposable instruments and as stand-alone forcost savings
• No additional handling requirements or freezer storage required
Comprised of OSSIOfiber™ Intelligent Bone Regeneration Technology
• Strong, secure fixation for PIP fusions
• Fully integrates into native anatomy without adverse inflammation, as proven in pre-clinical studies
• Visible yet artifact-free on CT and X-ray, MRI safe
Three sizes (2.5 mm, 2.9 mm, and 3.2 mm)Two orientations (0º and 10º) Implant
pre-loaded on Inserter
CT and X-Ray Imaging
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Data on File at OSSIO. Not available for sale outside the US.
Kit ordering information
Hammertoe Fixation Implant
*Implants are packaged pre-loaded on an inserter.†Instrument kits include a Drill Bit and K-Wire.
Disposable kits (implant + instrumentation) and stand-alone implants are available in 3 sizes (small, medium, and large) and in 2 orientations (straight and angled).
Size Description Product Code
Small
OSSIOfiber™ Hammertoe Fixation Implant 2.5 x 16 mm, 0° Straight*
OF10025160
OSSIOfiber™ Hammertoe Fixation System 2.5 x 16 mm, 0° Straight Implant and Instrument Kit† OF20025160
OSSIOfiber™ Hammertoe Fixation Implant 2.5 x 16 mm, 10° Angled*
OF10025161
OSSIOfiber™ Hammertoe Fixation System 2.5 x 16 mm, 10° Angled Implant and Instrument Kit† OF20025161
Medium
OSSIOfiber™ Hammertoe Fixation Implant 2.9 x 19 mm, 0° Straight*
OF10029190
OSSIOfiber™ Hammertoe Fixation System 2.9 x 19 mm, 0° Straight Implant and Instrument Kit†
OF20029190
OSSIOfiber™ Hammertoe Fixation Implant 2.9 x 19 mm, 10° Angled*
OF10029191
OSSIOfiber™ Hammertoe Fixation System 2.9 x 19 mm, 10° Angled Implant and Instrument Kit† OF20029191
Large
OSSIOfiber™ Hammertoe Fixation Implant 3.2 x 21 mm, 0° Straight*
OF10032210
OSSIOfiber™ Hammertoe Fixation System 3.2 x 21 mm, 0° Straight Implant and Instrument Kit† OF20032210
OSSIOfiber™ Hammertoe Fixation Implant 3.2 x 21 mm, 10° Angled*
OF10032211
OSSIOfiber™ Hammertoe Fixation System 3.2 x 21 mm, 10° Angled Implant and Instrument Kit† OF20032211
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Artifact-free CT and X-Ray Imaging OSSIOfiber™ Intelligent Bone Regeneration Technology has similar radiodensity to cortical bone for artifact-free CT and X-Ray, MR safe imaging. The images below show a 2nd toe proximal interphalangeal (PIP) joint fusion with the Medium, Straight OSSIOfiberTM Hammertoe Implant.
Patient x-rays are representative of a selection of patients of similar demographics who underwent identical surgical approaches and have reached the indicated follow up time points. Results are not predictive of results in other cases. Results may vary.
Post-operative X-Ray
Post-operative CT Scan
6-week CT Scan
Post-Operative X-Ray
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Artifact-free CT and X-Ray Imaging OSSIOfiber™ Intelligent Bone Regeneration Technology has similar radiodensity to cortical bone for artifact-free CT and X-Ray, MR safe imaging. The images below show a 2nd toe proximal interphalangeal (PIP) joint fusion with the Medium, Straight OSSIOfiberTM Hammertoe Implant.
Patient x-rays are representative of a selection of patients of similar demographics who underwent identical surgical approaches and have reached the indicated follow up time points. Results are not predictive of results in other cases. Results may vary.
12-Week CT Scan
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Artifact-free CT and X-Ray Imaging OSSIOfiber™ Intelligent Bone Regeneration Technology has similar radiodensity to cortical bone for artifact-free CT and X-Ray, MR safe imaging. The images below show a 2nd toe proximal interphalangeal (PIP) joint fusion with the Medium, Straight OSSIOfiberTM Hammertoe Implant.
Patient x-rays are representative of a selection of patients of similar demographics who underwent identical surgical approaches and have reached the indicated follow up time points. Results are not predictive of results in other cases. Results may vary.
12-Week X-Ray
INTRODUCTION
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PRODUCT INFORMATION
Artifact-free CT and X-Ray Imaging OSSIOfiber™ Intelligent Bone Regeneration Technology has similar radiodensity to cortical bone for artifact-free CT and X-Ray, MR safe imaging. The images below show a 2nd toe proximal interphalangeal (PIP) joint fusion with the Medium, Straight OSSIOfiberTM Hammertoe Implant.
Patient x-rays are representative of a selection of patients of similar demographics who underwent identical surgical approaches and have reached the indicated follow up time points. Results are not predictive of results in other cases. Results may vary.
6 Month Post-Operative X-Rays
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PRODUCT INFORMATION
Artifact-free CT and X-Ray Imaging OSSIOfiber™ Intelligent Bone Regeneration Technology has similar radiodensity to cortical bone for artifact-free CT and X-Ray, MR safe imaging. The images below show a 2nd toe proximal interphalangeal (PIP) joint fusion with the Medium, Straight OSSIOfiberTM Hammertoe Implant.
Patient x-rays are representative of a selection of patients of similar demographics who underwent identical surgical approaches and have reached the indicated follow up time points. Results are not predictive of results in other cases. Results may vary.
6 Month Post-Operative X-Rays
INTRODUCTION
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PRODUCT INFORMATION
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PRODUCT INFORMATION
PIP arthrodesis surgical techniqueUsing the OSSIOfiber™ Hammertoe Fixation Implant The OSSIOfiber™ Hammertoe Fixation Implant provides the necessary strength for proximal interphalangeal (PIP) fusion procedures with a bio-integrative intermedullary implant made from OSSIOfiber™ Intelligent Bone Regeneration Technology. This proprietary material technology is comprised of natural mineral fibers engineered into a high-performing matrix suspended within a Poly-L-D-lactide (PLDLA) polymer. OSSIOfiber™ material gradually incorporates into the surrounding anatomy, leaving nothing permanent behind.
Surgical Technique Guide
Prepare JointResect both sides of the joint, perpendicular to the dorsal cortex, with an oscillating saw or rongeur. Drill the provided K-wire into the medullary canal of the proximal and middle phalanx. Note: Ensure K-wire is parallel to the dorsal cortex during drilling for optimal tunnel placement.
1
Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.
INTRODUCTION
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SURGICAL TECHNIQUE
Surgical Technique Guide
Prepare JointResect both sides of the joint, perpendicular to the dorsal cortex, with an oscillating saw or rongeur. Drill the provided K-wire into the medullary canal of the proximal and middle phalanx. Note: Ensure K-wire is parallel to the dorsal cortex during drilling for optimal tunnel placement.
1
Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.
–
Prepare Proximal PhalanxUsing the pilot hole created by the K-wire, drill a tunnel in the proximal phalanx referencing the proximal laser mark on the drill bit for the recommended tunnel length.
Surgical Technique Guide
2
Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.
PIP arthrodesis surgical techniqueUsing the OSSIOfiber™ Hammertoe Fixation Implant The OSSIOfiber™ Hammertoe Fixation Implant provides the necessary strength for proximal interphalangeal (PIP) fusion procedures with a bio-integrative intermedullary implant made from OSSIOfiber™ Intelligent Bone Regeneration Technology. This proprietary material technology is comprised of natural mineral fibers engineered into a high-performing matrix suspended within a Poly-L-D-lactide (PLDLA) polymer. OSSIOfiber™ material gradually incorporates into the surrounding anatomy, leaving nothing permanent behind.
INTRODUCTION
MATERIAL COMPONENTS
STRENGTH
BIO-INTEGRATIVE
COMPETITIVE COMPARISON
PRODUCT INFORMATION
SURGICAL TECHNIQUE
COMPANY OVERVIEW
SUMMARY
SURGICAL TECHNIQUE
+
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SURGICAL TECHNIQUE
Surgical Technique Guide
Prepare Proximal PhalanxUsing the pilot hole created by the K-wire, drill a tunnel in the proximal phalanx referencing the proximal laser mark on the drill bit for the recommended tunnel length.
2
Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.
–
Prepare Middle PhalanxCreate a second tunnel in the middle phalanx referencing the distal laser line on the drill bit for the recommended tunnel length.
Surgical Technique Guide
3
Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.
+
PIP arthrodesis surgical techniqueUsing the OSSIOfiber™ Hammertoe Fixation Implant The OSSIOfiber™ Hammertoe Fixation Implant provides the necessary strength for proximal interphalangeal (PIP) fusion procedures with a bio-integrative intermedullary implant made from OSSIOfiber™ Intelligent Bone Regeneration Technology. This proprietary material technology is comprised of natural mineral fibers engineered into a high-performing matrix suspended within a Poly-L-D-lactide (PLDLA) polymer. OSSIOfiber™ material gradually incorporates into the surrounding anatomy, leaving nothing permanent behind.
INTRODUCTION
MATERIAL COMPONENTS
STRENGTH
BIO-INTEGRATIVE
COMPETITIVE COMPARISON
PRODUCT INFORMATION
SURGICAL TECHNIQUE
COMPANY OVERVIEW
SUMMARY
SURGICAL TECHNIQUE
INTRODUCTION
MATERIAL COMPONENTS
STRENGTH
BIO-INTEGRATIVE
COMPETITIVE COMPARISON
PRODUCT INFORMATION
SURGICAL TECHNIQUE
COMPANY OVERVIEW
SUMMARY
SURGICAL TECHNIQUE
Surgical Technique Guide
Prepare Middle PhalanxCreate a second tunnel in the middle phalanx referencing the distal laser line on the drill bit for the recommended tunnel length.
3
Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.
–
Fixate Implant Insert the proximal end of the OSSIOfiber™ Hammertoe Fixation Implant into the proximal phalanx until the stopper is reached, using the implant holder.
Surgical Technique Guide
4
Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.
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PIP arthrodesis surgical techniqueUsing the OSSIOfiber™ Hammertoe Fixation Implant The OSSIOfiber™ Hammertoe Fixation Implant provides the necessary strength for proximal interphalangeal (PIP) fusion procedures with a bio-integrative intermedullary implant made from OSSIOfiber™ Intelligent Bone Regeneration Technology. This proprietary material technology is comprised of natural mineral fibers engineered into a high-performing matrix suspended within a Poly-L-D-lactide (PLDLA) polymer. OSSIOfiber™ material gradually incorporates into the surrounding anatomy, leaving nothing permanent behind.
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Surgical Technique Guide
Fixate Implant Insert the proximal end of the OSSIOfiber™ Hammertoe Fixation Implant into the proximal phalanx until the stopper is reached, using the implant holder.
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Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.
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Align and ReduceManually reduce the middle phalanx over the distal end of the OSSIOfiber™ Hammertoe Fixation Implant, applying slow, steady pressure until bone-to-bone contact is achieved. Complete the procedure by routine closure using preferred technique.
Surgical Technique Guide
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Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.
+
PIP arthrodesis surgical techniqueUsing the OSSIOfiber™ Hammertoe Fixation Implant The OSSIOfiber™ Hammertoe Fixation Implant provides the necessary strength for proximal interphalangeal (PIP) fusion procedures with a bio-integrative intermedullary implant made from OSSIOfiber™ Intelligent Bone Regeneration Technology. This proprietary material technology is comprised of natural mineral fibers engineered into a high-performing matrix suspended within a Poly-L-D-lactide (PLDLA) polymer. OSSIOfiber™ material gradually incorporates into the surrounding anatomy, leaving nothing permanent behind.
INTRODUCTION
MATERIAL COMPONENTS
STRENGTH
BIO-INTEGRATIVE
COMPETITIVE COMPARISON
PRODUCT INFORMATION
SURGICAL TECHNIQUE
COMPANY OVERVIEW
SUMMARY
SURGICAL TECHNIQUE
INTRODUCTION
MATERIAL COMPONENTS
STRENGTH
BIO-INTEGRATIVE
COMPETITIVE COMPARISON
PRODUCT INFORMATION
SURGICAL TECHNIQUE
COMPANY OVERVIEW
SUMMARY
SURGICAL TECHNIQUE
Surgical Technique Guide
Align and ReduceManually reduce the middle phalanx over the distal end of the OSSIOfiber™ Hammertoe Fixation Implant, applying slow, steady pressure until bone-to-bone contact is achieved. Complete the procedure by routine closure using preferred technique.
5
Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.
–
Refer to the product Instructions for Use for warnings, precautions, indications, contraindications, and technique. Medical professionals must use their professional judgment for patient selection and appropriate technique. Data on File at OSSIO. Not available for sale outside the US.
+
PIP arthrodesis surgical techniqueUsing the OSSIOfiber™ Hammertoe Fixation Implant The OSSIOfiber™ Hammertoe Fixation Implant provides the necessary strength for proximal interphalangeal (PIP) fusion procedures with a bio-integrative intermedullary implant made from OSSIOfiber™ Intelligent Bone Regeneration Technology. This proprietary material technology is comprised of natural mineral fibers engineered into a high-performing matrix suspended within a Poly-L-D-lactide (PLDLA) polymer. OSSIOfiber™ material gradually incorporates into the surrounding anatomy, leaving nothing permanent behind.
INTRODUCTION
MATERIAL COMPONENTS
STRENGTH
BIO-INTEGRATIVE
COMPETITIVE COMPARISON
PRODUCT INFORMATION
SURGICAL TECHNIQUE
COMPANY OVERVIEW
SUMMARY
SURGICAL TECHNIQUE
Who we are
OSSIO Israel HQ
Dedicated to pioneering a breakthrough category of non-permanent fixationOSSIO is an orthopedic fixation company committed to transforming the orthopedic experience for patients, physicians, and payers. Our vision is to provide the first credible replacement to metal implants in the $10B+ orthopedic fixation market (screws, pins, and plates) with an Intelligent Bone Regeneration Technology. OSSIOfiber™ represents a breakthrough material platform for orthopedic and podiatric surgeons who seek a more biologically friendly way to restore patient stability and mobility with nothing permanent left behind. The development headquarters of OSSIO are in Caesarea, Israel, and its commercial headquarters are in Boston, Massachusetts.
Developing the right balance of strength and bio-friendlinessIn 2014, OSSIO began as the culmination of years of biomechanical research and a vision for the possibility of better bone healing. The technological basis of OSSIOfiber™ was developed and laid the groundwork for a breakthrough category of non-permanent fixation: bio-integrative hardware that has both the desired strength AND bio-friendliness. Hardware that has the mechanical strength for easy insertion and secure fixation while enabling the body to regrow bone to incorporate and replace the implant has remained elusive to the industry until now. Adverse inflammation and weakness are often seen in bioresorbables and other bio-composites.
Manufacturing area
OSSIO strives to become THE gold standard in orthopedic fixation by encouraging natural bone healing that will ultimately eliminate hardware removal procedures, minimize implant-related complications, alleviate pain, and dramatically improve the healthcare economics of orthopedics.
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Naturally Transformative Bone HealingOSSIOfiber™ enables intelligent bone regeneration with nothing left behind.
For more on OSSIO and OSSIOfiber™, please visit ossio.io, call 833-781-7373 or email [email protected]
Additional Information
Vast Surgical Applications
Utilizes Existing Reimbursement and Surgical Techniques
Bone In-Growth, Regeneration, and Replacement
Avoids Risks and Costs Associated with Permanent Implants
Strong, Secure Fixations
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DOC000341 Rev 02 08/2019DOC000342 Rev 01 12/2018 DOC000343 Rev 03 08/2019 DOC000345 Rev 01 08/2019 DOC000346 Rev 02 08/2019DOC000688 Rev 01 07/2019
References: 1. Ambrose CG, Clanton TO. Bioabsorbable implants: review of clinical experience in orthopedic surgery. Ann Biomed Eng. 2004;32(1):171–177. 2. Kontakis GM, Pagkalos JE, Tosounidis TI, Melissas J, Katonis P. Bioabsorbable materials in orthopaedics. Acta Orthop Belg. 2007;73(2):159–169. 3. Cox CL, Spindler KP, Leonard JP, Morris BJ, Dunn WR, Reinke EK. Do newer-generation bioabsorbable screws become incorporated into bone at two years
after ACL reconstruction with patellar tendon graft?: a cohort study. J Bone Joint Surg Am. 2014;96(3):244–250. 4. Konan S, Haddad FS. A clinical review of bioabsorbable interference screws and their adverse effects in anterior cruciate ligament reconstruction surgery.
Knee. 2009;16(1):6–13. 5. Pre-clinical animal studies (in-bone implantation of OSSIOfiber™ and PLDLA control in rabbit femurs). Data on File at OSSIO.
Not available for sale outside the US.
OSSIO and OSSIOfiber are trademarks of OSSIO Ltd.OSSIO Inc, 300 Tradecenter Drive, Suite 3690, Woburn, MA 01801www.ossio.io | email: [email protected] | phone number: 833-781-7373
Summary
INTRODUCTION
MATERIAL COMPONENTS
STRENGTH
BIO-INTEGRATIVE
COMPETITIVE COMPARISON
PRODUCT INFORMATION
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SUMMARYSUMMARY