UNIGLIDE UNICONDYLAR KNEE PROSTHESIS

K050764 · Corin USA · HRY · Aug 24, 2005 · Orthopedic

Device Facts

• Record ID: K050764
• Device Name: UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
• Applicant: Corin USA
• Product Code: HRY · Orthopedic
• Decision Date: Aug 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Uniglide unicondylar knee replacement system is indicated for use in the replacement of the articulating surfaces of one tibio-femoral compartment of the knee where this has been affected by primary degenerative disease, post traumatic degenerative disease or damage due to previous surgical intervention. The device is indicated in these cases where the degeneration is substantially limited to the compartment to be replaced and the anterior and posterior cruciate ligaments are present and functionally intact. The device is indicated for use in the medial or lateral compartment of the knee. The device is intended to be used with bone cement. The device is intended for prescription use only.

Device Story

Uniglide Unicondylar Knee Replacement System; semi-constrained, cemented, metal/polymer prosthesis. Components: Cobalt Chrome (CoCr) alloy femoral component; ultra-high molecular weight polyethylene (UHMWPE) tibial component. Used in orthopedic surgery to replace articulating surfaces of one tibio-femoral compartment (medial or lateral) in patients with degenerative disease or post-traumatic damage. Requires intact cruciate ligaments. Surgeon implants device using bone cement to restore joint function and alleviate pain associated with localized knee degeneration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Cobalt Chrome (CoCr) alloy femoral component, UHMWPE tibial component. Design: Semi-constrained, cemented, metal/polymer knee prosthesis. Classification: 21 CFR 888.3530, Product Code HRY.

Indications for Use

Indicated for patients requiring replacement of one tibio-femoral knee compartment due to primary degenerative disease, post-traumatic degenerative disease, or prior surgical damage. Requires intact anterior and posterior cruciate ligaments. Indicated for medial or lateral compartment use. Intended for use with bone cement.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Vanguard M™ Series Unicondylar Tibial Bearings (K042093)
• Repicci II™ Unicondylar Knee (K980665)
• Link Endo-Model™ Sled Uniknee (K954186)
• UC Plus Solution Unicondylar Knee System (K982859)

Submission Summary (Full Text)

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K050764

## AUG 2 4 2005

## 510(k) Summary

Date:

3/1/05

Applicant Name:

Corin Group PLC The Corinium Centre Cirencester Gloucestershire GL7 1YJ United Kingdom

Richard Sharp Contact Person: Regulatory Affairs Director Corin Group PLC [phone]

Proprietary Name: Uniglide™ Unicondylar Knee Replacement System

Common Name: Unicompartmental knee replacement

Classification Name: Prosthesis, knee, femerotibial, semi-constrained, cemented, metal/polymer (21 CFR 888.3530)

Class/Product Code: Class II / HRY

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Substantially Equivalent Devices: Vanguard M™ Series Unicondylar Tibial Bearings (K042093); Repicci II™ Unicondylar Knee (K980665); Link Endo-Model™ Sled Uniknee (K954186); UC Plus Solution Unicondylar Knee System (K982859)

Device Description: The device consists of Cobalt Chrome (CoCr) alloy femoral component which articulates against an ultra high molecular polyethylene (UHMWPE) tibial component.

Indications for Use: Replacement of the articulating surfaces of one tibio-femoral compartment of the knee where this has been affected by primary degenerative disease, post traumatic degenerative disease or damage due to previous surgical intervention and the anterior and posterior cruciate ligaments are present and functionally intact. The device is indicated for use in the medial or lateral compartment of the knee and is intended to be used with bone cement.

Basis for Substantial Equivalence: The sponsor claims substantial equivalence (SE) of the Uniglide Unicondylar Knee Replacement System to the previously approved Vanguard M series, Recippi II, Link Endo-Model Sled and UC Plus Solution unicondylar knees (see Table 1).

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized eagle with three lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

AUG 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joel K. Batts Director, US Regulatory Affairs Corin U.S.A. 10500 University Center Drive Suite 190 Tampa, Florida 33612

Re: K050764

Trade/Device Name: Uniglide Unicondylar Knee Replacement System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: August 03, 2005 Received: August 05, 2005

Dear Mr. Sharp:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalled is (c) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to may 20, 2017 accordance with the provisions of the Federal Food, Drug, de rices that have been recise approval of a premarket approval application (PMA). and Cosmete Ace (11et) that do nevice, subject to the general controls provisions of the Act. The r ou may, therefere, mains of the Act include requirements for annual registration, listing of general controls provision of the stative, 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 may be subject to sater additions, 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I oderal statutes and states and mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 6077, labeling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by stone (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Joel K. Batts

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your intial equivalence of your device to a legally premainct notification: "The PDF intember of the sification 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 If you desire specific advice 10. Jour 2011) 276-0120. Also, please note the regulation entitled, Colliation of Compullier in (21 CFR Part 807.97). You may obtain Missuranting of Telefono to premailsonibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

Mark N. Melkerson ಕ್ಕೆ ಕ Acting 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): KOSO 764

Device Name: Uniglide Unicondylar Knee Replacement System

## Indications for Use:

The Uniglide unicondylar knee replacement system is indicated for use in the replacement of the articulating surfaces of one tibio-femoral compartment of the knee where this has been affected by primary degenerative disease, post traumatic degenerative disease or damage due to previous surgical intervention. The device is indicated in these cases where the degeneration is substantially limited to the compartment to be replaced and the anterior and posterior cruciate ligaments are present and functionally intact. The device is indicated for use in the medial or lateral compartment of the knee. The device is intended to be used with bone cement. The device is intended for prescription use only.

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

Over-The-Counter Use NO (21 CFR 801 Subpart C)

Signature

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

510(k) Number_KO50 364 Concurrence of CDRH, Office of Device Evaluation (ODE)