The Hybrid Knee Femoral Components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.

Indications include:

post-traumatic arthritis; .
degenerative arthritis; and ●
failed osteotomies, hemiarthroplasties; and unicompartmental replacement .

These indications will be used for the Hybrid Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.

The Hybrid Knee Femoral Components are single use only and are intended for implantation only with bone cement.

Device Description

The Smith & Nephew Hybrid Knee Femoral Components are designed for use with tibial components of the Genesis I Unicondylar Knee System and patellar components of the Genesis II Total Knee System. The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint.

AI/ML Overview

Acceptance Criteria and Study for Smith & Nephew Hybrid Knee Femoral Components

Based on the provided document, the Smith & Nephew Hybrid Knee Femoral Components were cleared through a 510(k) premarket notification process, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific performance acceptance criteria against a defined clinical outcome. Therefore, the "acceptance criteria" here refers to the demonstration of equivalence through mechanical testing and comparison of design, indications, and materials.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Performance	Capability of withstanding expected in vivo loading without failure. Assessed against "devices currently used clinically."	"A review of the mechanical test data indicated that the Smith & Nephew Hybrid Knee Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure."
Design Features	Similarities in design features to existing components of the Genesis I Unicondylar Knee System, Genesis II Total Knee System, and other commercially available patellofemoral joint prostheses.	"The substantial equivalence of the Smith & Nephew Hybrid Knee Femoral Components is substantiated by its similarities in design features... as existing components of the Genesis I Unicondylar Knee System and Genesis II Total Knee Systems distributed by Smith & Nephew, Inc., as well as other commercially available patellofemoral joint prostheses."
Overall Indications	Similarities in overall indications to existing components of the Genesis I Unicondylar Knee System, Genesis II Total Knee System, and other commercially available patellofemoral joint prostheses. Also, specific indications for use as listed.	"The substantial equivalence of the Smith & Nephew Hybrid Knee Femoral Components is substantiated by its similarities in... overall indications... as existing components of the Genesis I Unicondylar Knee System and Genesis II Total Knee Systems distributed by Smith & Nephew, Inc., as well as other commercially available patellofemoral joint prostheses."Specific Indications for Use listed: post-traumatic arthritis; degenerative arthritis; failed osteotomies, hemiarthroplasties; and unicompartmental replacement, affecting the medial condyle and patellofemoral regions.
Material Composition	Similarities in material composition to existing components of the Genesis I Unicondylar Knee System, Genesis II Total Knee System, and other commercially available patellofemoral joint prostheses.	"The substantial equivalence of the Smith & Nephew Hybrid Knee Femoral Components is substantiated by its similarities in... material composition as existing components of the Genesis I Unicondylar Knee System and Genesis II Total Knee Systems distributed by Smith & Nephew, Inc., as well as other commercially available patellofemoral joint prostheses."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical data for evaluating device performance. The assessment relies on mechanical test data and a comparison to existing devices. Therefore:

Sample size for test set: Not explicitly stated for mechanical testing, but general practice for such devices would involve multiple samples for various mechanical tests (e.g., fatigue, static strength).
Data provenance: Mechanical test data would typically be generated in a laboratory setting. Clinical "data provenance" (e.g., country of origin, retrospective/prospective) is not applicable here as a clinical study was not conducted to establish performance for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the document describes a 510(k) submission relying on substantial equivalence, not a clinical study requiring expert ground truth establishment for a test set. The "ground truth" for mechanical performance is based on established engineering principles and benchmarks from predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set requiring expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC comparative effectiveness study was not conducted or mentioned in the provided document. The submission relies on mechanical equivalence and comparison to predicate devices, not on a study demonstrating improved human reader performance with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable as the device is a physical knee femoral component, not an algorithm or AI system.

7. Type of Ground Truth Used

For the mechanical performance, the "ground truth" can be considered as:

Established engineering standards and biomechanical principles: For evaluating the ability to withstand expected in vivo loading.
Performance of predicate legally marketed devices: The document states the mechanical data indicated equivalence to "devices currently used clinically," implying comparison to the established performance of existing predicate devices.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical medical implant, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device is a physical medical implant, not a machine learning model requiring a training set.

Summary

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Summary of Safety and Effectiveness

JAN 1 2 2005

Smith & Nephew, Inc.

Smith & Nephew Hybrid Knee Femoral Components

Contact Person and Address

Kim Kelly, Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc., Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566

Device Description

Device Classification Name

Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis, 21 CFR 888.3530

Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis, 21 CFR 888.3540

Indications for Use

Indications include:

post-traumatic arthritis; .
degenerative arthritis; and ●
failed osteotomies, hemiarthroplasties; and unicompartmental replacement .

These indications will be used for the Hybrid Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.

The Hybrid Knee Femoral Components are single use only and are intended for implantation only with bone cement.

page 1 of 2

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Mechanical and Clinical Data

A review of the mechanical test data indicated that the Smith & Nephew Hybrid Knee Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.

Substantial Equivalence Information

The substantial equivalence of the Smith & Nephew Hybrid Knee Femoral Components is substantiated by its similarities in design features, overall indications, and material composition as existing components of the Genesis I Unicondylar Knee System and Genesis II Total Knee Systems distributed by Smith & Nephew, Inc., as well as other commercially available patellofemoral joint prostheses.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus, which is a traditional symbol of medicine.

JAN 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kim P. Kelly Project Manager Clinical and Regulatory Affairs Smith & Nephew, Inc., Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116

Re: K042896

Trade/Device Name: Hybrid Knee Femoral Components Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: NPJ Dated: October 19, 2004 Received: October 20, 2004

Dear Ms. Kelly:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the 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.

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Page 2 - Mrs. Kelly

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milleros

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K042896

Device Name: Hybrid Knee Femoral Components

Indications for Use:

Indications include:

post-traumatic arthritis; .
degenerative arthritis; and .
failed osteotomies, hemiarthroplasties; and unicompartmental . replacement

These indications will be used for the Hybrid Knee Femoral Components. whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.

The Hybrid Knee Femoral Components are single use only and are intended for implantation only with bone cement

Prescription × AND/OR Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

I. Restorative. and Neurologic

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510(k) Number

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.