The Competitor Unicondylar Tibial Baseplate Components are indicated for restoring either compartment of a knee that has been affected by the following:

Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or . avascular necrosis;
. correction of functional deformity;
트 revision procedures where other treatments or devices have failed; and
treatment of fractures that are unmanageable using other techniques

The baseplate components are single use only and are intended for implantation only with bone cement.

Device Description

New unicondylar knee tibial baseplate components have been designed and developed by Smith & Nephew Orthopaedics. The subject devices are metal-backed tibial baseplates that are designed to be used with specific articular inserts. The overall designs of the components are based upon the existing Genesis Unicompartmental tibial implants subject of K912735.

AI/ML Overview

The provided document is a 510(k) summary for a medical device: "Smith & Nephew Competitor Unicondylar Tibial Baseplate Components." This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device, not on proving clinical effectiveness or efficacy through acceptance criteria and detailed clinical studies as would be required for a PMA (Premarket Approval) application or a de novo classification.

Therefore, the document does not contain the information requested regarding:

A table of acceptance criteria and reported device performance.
Sample sizes used for test and training sets, data provenance, ground truth establishment, or expert qualifications.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.

The 510(k) summary states that "The Smith & Nephew Competitor Unicondylar Tibial Baseplate Components are similar to the following commercially available devices regarding design features, overall indications, and materials: Smith & Nephew Genesis Unicompartmental Knee System (K912735) and Smith & Nephew Unicondylar Femoral Component (K030301)."

This statement is the "study" and "acceptance criteria" in the context of a 510(k). The acceptance criterion is that the new device is "substantially equivalent" in design, indications, and materials to the predicate devices. The "proof" is the detailed comparison submitted by the manufacturer (which is not fully contained in this summary document) demonstrating this substantial equivalence.

In summary, the information requested is not applicable or available in this 510(k) submission document. This document is for a medical implant (knee prosthesis components), not an AI/software device that would typically involve the types of performance metrics and studies you've asked about (e.g., sensitivity, specificity, reader studies).

Summary

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K061011 (pg 1 of 1)

510(K) Summary

JUL 1 1 2006

Smith & Nephew Competitor Unicondylar Tibial Baseplate Components

SUBMITTER'S NAME:	Smith & Nephew, Inc., Orthopaedic Division
SUBMITTER'S ADDRESS:	1450 East Brooks Road, Memphis, TN 38116
SUBMITTER'S TELEPHONE NUMBER:	901-399-6707
CONTACT PERSON:	Gino J. Rouss
DATE SUMMARY PREPARED:	April 10, 2006
TRADE OR PROPRIETARY DEVICE NAME:	Smith & Nephew Competitor Unicondylar Tibial Baseplate Components
COMMON OR USUAL NAME:	Knee Prosthesis
CLASSIFICATION NAME:	Knee joint femorotibial metal/polymer non-constrained cemented prosthesis, 21 CFR 888.3520
DEVICE CLASS:	Class II
PANEL CODE:	HSX Orthopedics Panel/87

A. INTENDED USE:

The Competitor Unicondylar Tibial Baseplate Components are indicated for restoring either compartment of a knee that has been affected by the following:

Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or . avascular necrosis;
. correction of functional deformity;
트 revision procedures where other treatments or devices have failed; and
treatment of fractures that are unmanageable using other techniques

The baseplate components are single use only and are intended for implantation only with bone cement.

B. DEVICE DESCRIPTION:

C. SUBSTANTIAL EQUIVALENCE INFORMATION:

The Smith & Nephew Competitor Unicondylar Tibial Baseplate Components are similar to the following commercially available devices regarding design features, overall indications, and materials:

· Smith & Nephew Genesis Unicompartmental Knee System (K912735)
· Smith & Nephew Unicondylar Femoral Component (K030301)

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of community or collaboration. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, framing the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1 2006

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

Re: K061011

Trade/Device Name: Competitor Unicondylar Tibial Baseplate Components Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX Dated: April 10, 2006 Received: April 12, 2006

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, Dr u 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, incl. Ast. A 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

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Page 2 -- Mr. Gino J. Rouss

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. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buchun
to
Mark N. Melin

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

KO61011

Device Name: Competitor Unicondylar Tibial Baseplate Components

Indications for Use:

The Competitor Unicondylar Tibial Baseplate Components are indicated for restoring either compartment of a knee that has been affected by the following:

Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or . avascular necrosis;
correction of functional deformity; ●
revision procedures where other treatments or devices have failed; and .
treatment of fractures that are unmanageable using other techniques ●

The baseplate components are for single use only and are intended for implantation only with bone cement.

Prescription Use x (Part 21 CFR 801 Subpart D)

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 Division of General. Restorative. and Neurological Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number K061011

Regulation Number and Section

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.