Experience the freedom of robotics in your hands

2 NAVIO design rationale

The need for improvements in healthcare

Knee arthroplasty has a highly successful track record as a surgical intervention, yet patient satisfaction ratings indicate up to 25% of patients remain dissatisfied 1-4

Patient satisfaction after total knee replacement is directly related to knee stability and proprioception, particularly for high-demand, active patients5-6

Knee arthroplasty patient satisfaction ratings

Why Are Total Knee Arthroplasties Failing Today?7

Most knee revisions were due to instability or malalignment

• Better alignment and improved outcomes may result in less wear and better implant survivorship*

• Knee implants may last longer when accurately aligned

Sharkey PF, et al. Clinical Orthopaedics and Related Research. 2002;404:7-13.

25%

NAVIO design rationale 3

The evolution of robotics technology

The NAVIO™ Surgical SystemThe freedom of robotics in your hands

Experience the freedom of handheld robotics and deliver the accuracy8-11 patients deserve

The freedom of handheld robotics

The value of an expandable robotics program

The accuracy8-11 patients deserve

Conventional Instruments

Navigation tool

Early Robotics

Handheld Robotics

Balancing Instruments

Computer Assisted Surgery

Surgical guide/execution accuracy/ image-based system

Surgical guide/execution accuracy/kinematic, gap balancing/ image-free system

Early balance tool

4 NAVIO design rationale

How it works

Image-free registrationIn real time, the surgeon characterizes the patient’s bone and cartilage through a sequence of landmark collection and point mapping – no preoperative image required.

Patient specific planningDesigned to eliminate extensive ligament releases by visualizing cuts and gap balancing prior to bone preparation, the surgeon can customize a plan based on the goal for each individual patient using mechanical alignment and ligament data.

Robotics-assisted bone preparationUsing one of two robotic assisted control modes, the surgeon can execute the patient-specific plan with a high level of accuracy.8-16

ConfirmationUpon case completion, surgeon can assess initial outcome of both long leg alignment and knee balance.

NAVIO design rationale 5

The freedom of handheld robotics

NAVIO™ – the only handheld robotics-assisted surgical system for knee arthroplasty

NAVIO handheld robotic-assisted bone removal techniques

Robotic control modes• Exposure control: The bur extends or retracts from guard based on proximity to target cut surface

• Speed control: The exposed bur speed is adjusted based on proximity to target cut surface

•

•

•

•

•

•

Bur all: • Burr All Tibia techique is

possible as an alternative to the Hybrid method Bur + standard cutting block for TKAs

• Bur All Tibia is mandatory for JOURNEY XR Tibia implant

Distal bur: • Hybrid of efficiency

and robotics

• Robotic-assisted means of preparing the distal femur for AP cut guide, using hybrid approach with burs and saws (TKA/XR)

Bur all: • Robotic purists – want

complete robotics methods

• Robotic-assisted method using bur only (UKA/XR/TKA)

6 NAVIO design rationale

Compact footprintDesigned for OR efficiency, the compact footprint is ideal for hospitals and surgery centers – easily move NAVIO™ as needed

Lower cost of ownership12 compared to other robotics-assisted platforms in the marketIn addition, real-time imaging in the OR eliminates time, costs and radiation exposure associated with preoperative CT imaging

The largest knee implant selection for robotics-assisted surgeryA consistent workflow is designed to reduce the learning curve with common software for UNI, PFJ, TKA (including XR)

Increase ORthroughput with additional handpieces

Cruciate Retaining (CR)

LEGION

LEGION w/ VERILAST™

LEGION™ Portfolio

JOURNEY II BCSJOURNEY II XR JOURNEY II CR JOURNEY UNI

JOURNEY™ II Portfolio

JOURNEY PFJ

GENESIS II PS/CR

GENESIS II w/OXINIUM™

GENESIS™ II Portfolio

GENESIS II 20 Year Knee

The value of an expandable robotics program

ANTHEM™ Portfolio

ANTHEM CR ANTHEM PS

NAVIO design rationale 7

A study has shown use of NAVIO can accurately prepare the bone surface of the tibia and femur, which allows for few errors resulting in high levels of accuracy* in the planned coronal mechanical axis alignment, when comparing planned versus achieved component placement.16 Better alignment and improved outcomes may result in less wear and better implant survivorship7*

The accuracy** achieved with NAVIO may help balance the knee through the range of motion, which has been shown to increase patient satisfaction13-15*

The accuracy8-11 patients deserve

NAVIO provides high accuracy* with implant placement9** and improved patient outcomes13***Lower cost of ownership

12 compared to other robotics-assisted platforms in the marketIn addition, real-time imaging in the OR eliminates time, costs and radiation exposure associated with preoperative CT imaging

JOURNEY PFJ

Smith & Nephew, Inc.

2905 Northwest Blvd., Suite 40 Plymouth, MN 55441 USA

Supporting healthcare professionals for over 150 years

References

1. Banerjee S, Cherian JJ, Elmallah RK, Jauregui JJ, Pierce TP, Mont MA. Robotic-assisted knee arthroplasty. Expert review of medical devices. 2015;12(6):727-735. 2. Urish KL, Conditt M, Roche M, Rubash HE. Robotic Total Knee Arthroplasty: Surgical Assistant for a Customized Normal Kinematic Knee. Orthopedics. 2016;39(5):e822-827. 3. Nodzo SR, Carroll KM, Mayman DJ. Disposable Navigation for Total Knee Arthroplasty. Am J Orthop (Belle Mead NJ). 2016;45(4):240-245. 4. Abdel MP, Oussedik S, Parratte S, Lustig S, Haddad FS. Coronal alignment in total knee replacement: historical review, contemporary analysis, and future direction. Bone Joint J. 2014;96-B:857–62. 5. Stiehl JB, Komistek RD, Cloutier JM, Dennis DA. The cruciate ligaments in total knee arthroplasty: a kinematic analysis of 2 total knee arthroplasties. J Arthroplasty. 2000;15:545-550. 6. Moro-oka TA, Muenchinger M, Canciani JP, Banks SA. Comparing in vivo kinematics of anterior cruciate-retaining and posterior cruciate-retaining total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2007;15:93-99. 7. Sharkey PF, Hozack WJ, Rothman, RH, Shastri S, Jacoby SM. Why Are Total Knee Arthroplasties Failing Today? Clinical Orthopaedics and Related Research. 2002;404:7-13. 8. Herry Y, Batailler C, Lording T, Servien E, Neyret P, Lustig S. Improved joint-line restitution in unicompartmental knee arthroplasty using a robotic-assisted surgical technique. Int Orthop. 2017;41:2265-2271. 9. Batailler C, White N, Ranaldi F, Neyret P, Servien E, Lustig S. Improved implant position and lower revision rate with robotic-assisted unicompartmental knee arthroplasty. European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA) 2018. 10. Jaramaz B, Nikou C, Casper M, Grosse S, Mitra R. Accuracy validation of semi-active robotic application for patellofemoral arthroplasty. Paper presented at: International Society for Computer Assisted Orthopaedic Surgery; June 17-20, 2015; Vancover, Canada. 11. Jaramaz B, Mitra R, Nikou C, Kung C. Technique and Accuracy Assessment of a Novel Image-Free Handheld Robot for knee Arthroplasty in Bi-Cruiciate Retaining Total Knee Replacement. EPiC Series in Health Sciences. 2018;2:98-101. K. 12. Data on file Smith & Nephew. Sg2 Healthcare Intelligence: Technology guide. 2014. 13. Gregori A, Picard F, Bellemans J, Smith J, Simone A. Handheld precision sculpting tool for unicondylar knee arthroplasty. A clinical re-view. Abstract presented at: 15th EFORT Congress; June 4-6, 2014; London, UK. 14. Smith JR, Picard F, Lonner J, Hamlin B, Rowe P, Riches P, Deakin A. The accuracy of a robotically-controlled freehand sculpting tool for unicondylar knee arthroplasty. Congress of the International Society of Biomechanics. 4-9 August, 2013. Natal, Brazil. 15. Gustke K, Golladay G, Roche MW, Jerry G, Elson LC, Anderson CR. Increased Patient Satisfaction After Total Knee replacement using sensor-guided technology. Bone Joint J 2014;96-B:1333–8. 16. Gregori A, Picard F, Lonner J, Smith J, Jaramaz B. Accuracy of imageless robotically assisted unicondylar knee arthroplasty. Paper presented at: International Society for Computer Assisted Orthopaedic Surgery; June 17-20, 2015; Vancover, Canada. *Compared to conventional techniques **With the use of the handpiece ***Compared to preoperative values

For detailed device information, including indications for use, contraindications, effects, precautions and warnings, please consult the product’s Instructions for Use (IFU) prior to use. The information contained herein may not be appropriate for all jurisdictions.

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