The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, unicompartmental replacement; or total knee arthroplasties. The components are designed for use 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 collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.

These indications are the same as currently used for the Genesis II Constrained Knee System and Revision Knee System cleared via K962137 and K041106.

Device Description

The Smith & Nephew Revision Knee System contains femoral knee components, tibial components, angled and offset couplers, stem attachments and wedges. The designs of these devices are based upon existing components of the Genesis II Total Knee System and Revision System, previously cleared for market under K951987, K953274, K962137, and K041106.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, specifically the SMITH & NEPHEW REVISION KNEE SYSTEM. These types of submissions typically demonstrate "substantial equivalence" to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria through clinical trials and statistical analysis.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria, device performance tables, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or how ground truth for the training set was established.

Here's why and what information is present:

Substantial Equivalence: The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics as the predicate device, or, if it has different technological characteristics, that the differences do not raise different questions of safety and effectiveness.
Focus of this Document: The document describes the device's intended use, its components, and lists predicate devices to which it claims substantial equivalence. It also lists general safety and effectiveness characteristics.
No Clinical Study Details: It does not mention any clinical study conducted to establish performance metrics against acceptance criteria. The focus is on comparing the new device to existing, already cleared devices.

Summary of available information related to your prompt, and why other requested information is not present:

A table of acceptance criteria and the reported device performance: This is not present. The document doesn't define specific numerical acceptance criteria for performance; rather, it asserts similarity to predicate devices.
Sample size used for the test set and the data provenance: This is not present. There's no mention of a "test set" in the context of clinical or performance data for this submission. The submission relies on the established safety and efficacy of predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not present. No such "ground truth" establishment is described for a performance study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not present. No adjudication method for a test set is mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not present. This device is a knee implant, not an AI-assisted diagnostic tool. MRMC studies are irrelevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not present. This device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This is not present, as no specific performance study with ground truth data is detailed.
The sample size for the training set: This is not present. This is not an AI/algorithm-based device that would require training data.
How the ground truth for the training set was established: This is not present.

In conclusion, the provided 510(k) summary is a regulatory document focused on proving "substantial equivalence" of a medical device (a knee implant) to already approved predicate devices, rather than a clinical study report detailing performance against specific acceptance criteria.

Summary

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K043440

510(K) Summary SMITH & NEPHEW REVISION KNEE SYSTEM

SUBMITTER'S NAME:	Smith & Nephew, Inc., Orthopaedic Division
SUBMITTER'S ADDRESS:	1450 Brooks Road, Memphis, TN 38116
SUBMITTER'S TELEPHONE NUMBER:	901-399-6707
CONTACT PERSON:	Gino J. Rouss
DATE SUMMARY PREPARED:	December 13, 2004
TRADE OR PROPRIETARY DEVICE NAME:	Revision Knee System
COMMON OR USUAL NAME:	Femoral Components, Tibial Components, Couplers, Wedges, and Stem Extensions
CLASSIFICATION NAME:	Knee Joint Patellofemorotibial Metal/Polymer/Metal Semi-Constrained Cemented Prosthesis
DEVICE CLASS:	Class II
PANEL CODE:	Orthopedics/87

DEVICE INFORMATION:

A. INTENDED USE:

These indications are the same as currently used for the Genesis II Constrained Knee System and Revision Knee System cleared via K962137 and K041106.

B. DEVICE DESCRIPTION:

C. SUBSTANTIAL EQUIVALENCE INFORMATION:

The Smith & Nephew Revision Knee System Components are similar to the following commercially available devices regarding design features, overall indications, and materials:

토 Smith & Nephew Revision Knee System (K041106)
Smith & Nephew Genesis II Total Knee System (K951987, K953274, K962137) 발
l Zimmer Legacy Constrained Condylar Knee (L-CCK)
Biomet Oncology Salvage System (OSS) 트
. Sulzer Orthopedics MOST" System

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2005

Mr. Gino J. Rouss Regulatory Affairs Specialist Smith & Nephew, Inc. 1450 E. Brooks Road Memphis, Tennessee 38116

Re: K043440

Trade/Device Name: Revision Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH

Dated: February 13, 2005 Received: February 14, 2005

Dear Mr. Rouss:

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, de need and have Act (Act) that do not require approval of a premarket approval application (PMA). and Oosmete ! Ios ( 10) wat 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 docs 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 – Mr. Gino J. Rouss

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/cdrl/industry/support/index.html.

Sincerely yours,
Mark N Milken

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): K043440

Device Name: Revision Knee System

Indications for Use:

The Revision Knee System Components are indicated for:

1. Rheumatoid arthritis.
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
1. Failed osteotomies, unicompartmental replacement, or total knee replacement.
1. The 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 collateral ligament) are absent or incompetent.

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

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

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

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510(k) Number K043440

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.