Rheumatoid arthritis.
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
Failed osteotomies, unicompartmental replacement, or total knee replacement.
Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral ligament) are incompetent.
Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral ligament) are absent or incompetent.
The Legion Hinge Knee System is for Cemented Use Only.

Device Description

Subject of this premarket notification is a material change to the femoral component and tibial trav in the Legion Hinge Knee System and design changes to the femoral component and axle. The Legion Hinge Knee System is used to treat gross knee instability resulting from loss of collateral ligament function, gross bone loss possibility including the insertion points of the collateral ligaments or patella tendon, or comminuted fractures of the proximal tibial or distal femur. Components of this premarket notification include the following components:

The femoral components manufactured from oxidized zirconium allov . (OXINIUM).
Design changes to the femoral component and axle ●
Tibial tray manufactured from Titanium alloy (Ti-6Al-4V). ●

AI/ML Overview

The provided document is a 510(k) summary for the Smith & Nephew Legion Hinge Knee System. It describes a medical device, a knee joint femorotibial metal/polymer constrained cemented prosthesis, and its substantial equivalence to predicate devices. The document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information, including:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for establishing ground truth.
Adjudication method.
MRMC comparative effectiveness study results.
Standalone performance results.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This document pertains to the regulatory submission for a physical medical device (knee implant) and focuses on mechanical performance testing and substantial equivalence to existing devices, not on the performance of an AI/ML algorithm or software.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

July 28, 2015

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Smith & Nephew Incorporated Ms. Allison Chan Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K151118

Trade/Device Name: Smith and Nephew Legion Hinge Knee System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: April 24, 2015 Received: April 30, 2015

Dear Ms. Chan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the

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Page 2 - Ms. Allison Chan

quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

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Submitted by:				We are smith&nephew510(k) SummaryLegion Hinge KneeSmith & Nephew, Inc.1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	July 24, 2015
Contact Person and Address:	Allison ChanRegulatory Affairs SpecialistT 901-399-1098F 901-566-7022
Name of Device:	Smith & Nephew, Inc. Legion Hinge Knee System
Common Name:	Total Knee Joint
Device Classification Name andReference:	21 CFR 888.3510 Knee joint femorotibial metal/polymerconstrained cemented prosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	KRO

Device Description

The femoral components manufactured from oxidized zirconium allov . (OXINIUM).
Design changes to the femoral component and axle ●
Tibial tray manufactured from Titanium alloy (Ti-6Al-4V). ●

Intended Use

The Smith & Nephew Legion Hinge Knee System is indicated for:

1. Rheumatoid arthritis.
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
1. Failed osteotomies, unicompartmental replacement, or total knee replacement.
1. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
1. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral ligament) are incompetent.
1. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral

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ligaments (i.e. medial collateral and/or lateral ligament) are absent or incompetent.

The Legion Hinge Knee System is for Cemented Use Only.

Comparison of Technological Characteristics with the Predicate Device

The Legion Hinge Knee System is substantially equivalent in design and fundamental scientific technology to the defined predicate device and does not raise any new issues of safety and efficacy. At a high level, the subject and predicate devices are based on the following same technological elements

Design-same articular geometry
Used as a total knee joint replacement .
Size range .
Use only with cement and single use .

The following technological differences exist between the subject and predicate devices

. Use of OXINIUM femoral components
Use of Titanium alloy tibial tray .
Design change in the femoral component and axle .

Performance Data

The following performance data was provided in support of the substantial equivalence determination

Fatigue Testing of OXINIUM Hinge Knee with hyperextension and Varus-● Valqus Loading
Anterior/Posterior Static Shear Testing ●
Construct Fatigue Testing of the OXINIUM Legion Hinge Knee at 30° Flexion. ●
. Torque to Failure Evaluation of the OXINIUM Legion Hinge Guided Motion Lock Screw

Substantial Equivalence Information

The substantial equivalence of the Legion Hinge Knee is based on similarities in function, intended use, indications for use, overall design to the predicate systems listed in the following table.

Table 5.1: Substantially Equivalent Predicates to the Legion Hinge Knee

Design AspectReviewed	Legion Hinge Knee	Legion Hinge Knee	Legion Revision
510(k) Number	Subject 510(k)	K081111	K043440
Manufacturer	Smith & Nephew	Smith & Nephew	Smith & Nephew
Similar Indications forUse	Yes	Yes	Yes
Similar SterilizationMethods	Yes	Yes	Yes
Femoral ComponentSize Offering Configuration Assembled or Stand-alone	FemoralComponent Yes Yes Assembly Configuration	Femoral Component Yes Yes Assembly and stand-alone	Femoral Component No Yes Stand-alone Configuration

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Design AspectReviewed	Legion Hinge Knee	Legion Hinge Knee	Legion Revision
Material Design	only(OXINIUMoxidizedzirconium) Internalthread on oneend	configurationCoCrMo Not threaded	OXINIUM(oxidizedzirconium) Not Applicable
Tibial Tray Size Offering Configuration Material	Tibial Tray Yes Yes Ti-6Al-4V	Tibial Tray Yes Yes CoCrMo	Tibial Tray No Yes Ti-6Al-4V
Axle Size Offering Design	Axle Yes Threaded onone end	Axle Yes Free floating	Not Applicable
Compatible KneeSystems	Yes	Not Applicable	Not Applicable

Table 5.1: Substantially Equivalent Predicates to the Legion Hinqe Knee

Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the Legion Hinge Knee System. Based on review of the mechanical testing performed, the devices are substantially equivalent to above predicate systems.

Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.