SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL

K052265 · Smith & Nephew, Inc. · NPJ · Dec 27, 2005 · Orthopedic

Device Facts

• Record ID: K052265
• Device Name: SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL
• Applicant: Smith & Nephew, Inc.
• Product Code: NPJ · Orthopedic
• Decision Date: Dec 27, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Competitor Duo 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 Competitor Duo Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions. The Competitor Duo Knee Femoral Components are single use only and are intended for implantation only with bone cement

Device Story

Competitor Duo Knee Femoral Components are orthopedic implants designed to replace the medial condyle and patellofemoral regions of the femoral knee joint. The device is intended for use in patients requiring multi-compartment knee reconstruction. The components are manufactured from Cobalt-Chromium (CoCr) or Oxinium. The device is implanted by an orthopedic surgeon in a clinical setting using bone cement. The design is based on the previously cleared Hybrid Knee Femoral Component. The implant serves to restore joint function and alleviate pain associated with arthritis or failed prior surgeries.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: Cobalt-Chromium (CoCr) and Oxinium. Form factor: Femoral knee joint component for medial condyle and patellofemoral replacement. Fixation: Cemented. Single-use.

Indications for Use

Indicated for patients with conditions affecting the medial condyle and patellofemoral regions of the knee that cannot be treated by single-compartment devices, including post-traumatic arthritis, degenerative arthritis, failed osteotomies, hemiarthroplasties, and unicompartmental replacement.

Regulatory Classification

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).

Predicate Devices

• Smith & Nephew Hybrid Knee Femoral (K042896)
• Genesis II and Legion (Revision) Knee Femorals (K962557 and K043440)

Reference Devices

• Smith & Nephew Hybrid Knee Femoral (K042896)

Submission Summary (Full Text)

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# DEC 2 7 2005

## 510(K) SUMMARY SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL COMPONENT

| 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: | August 17, 2005 |
| TRADE OR PROPRIETARY DEVICE<br>NAME: | Smith & Nephew Competitor Duo Knee Femoral |
| COMMON OR USUAL NAME: | Knee Femoral Replacement |
| CLASSIFICATION NAME: | Knee joint femorotibial metal/polymer semi-constrained<br>cemented prosthesis, 21 CFR 888.3530 |
| DEVICE CLASS: | Class II |
| PANEL CODE: | NPJ Orthopedics Panel/87 |

#### A. INTENDED USE:

The Competitor Duo Knee Femoral Components are intended to be used for those patients The Competitions exist that can not be solely addressed by a device that treats a single whereby ochaitions exist in the matellofemoral prosthesis) of the knee.

Indications include:

- · post-traumatic arthritis;
- · degenerative arthritis; and
- = failed osteotomies, and unicompartmental replacemental replacement

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

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

#### B. DEVICE DESCRIPTION:

D. BEVIOL DEOOKIPHON:
The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint. The Competitor Duo will include both CoCr and Oxinium femorals. The overall Knee joint. The Competitor Duo femoral component are based upon the existing Hybrid Knee Femoral Component subject of K042896.

### C. SUBSTANTIAL EQUIVALENCE INFORMATION:

The Smith & Nephew Competitor Duo Knee Femoral Components are similar to the following The Ommercially available devices regarding design features, overall indications, and materials:

- · Smith & Nephew Hybrid Knee Femoral (K042896)
- "Smith & Nephew Hyphd Rhoo Pomoral (Roll260)
= "Genesis II and Legion (Revision) Knee Femorals (Oxinium Material) (K962557 and K043440)

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 7 2005

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

K052265 Re:

Trade/Device Name: Competitor Duo Knee Femoral Components Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Il Product Code: NPJ Dated: December 13, 2005 Received: December 14, 2005

Dear Mr. Rouss:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed 5 our betermined 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 10 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). and Costietier rever roo, has the device, subject to the general controls provisions of the Act. The r ou may, mererors, mains 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 rr your device to such additional controls. Existing major regulations affecting your device can may or dato established 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 than i Dir has and regulations administered by other Federal agencies. You must

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### Page 2 – Mr. Gino J. Rouss

comply with all the Act's requirements, including, but not limited to: registration and listing (21 l comply with all the Act S requirements, mortalism and in a practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing pactice the electronic CFR Part 807); labeling (21 CFR Part 801); good and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 (21 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Sections over device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your daying to 1 l This letter will allow you to begin marketing your artial equivalence of your device to a legally premarket notification. The PDA miding of backanda experience 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
r the recultive and consembers and and any and the reculetion entitled If you desire specific advice for your device of the comments on the regulation entitled, Contact the Office of Compulation at (210) 210 cart 807.97). You may obtain "Misbranding by relefence to premation in the Act from the Division of Small other general international on your responsion.com its toll-free number [phone] or Manufacturers, International and Consailer Prosessor Prosisions of the new only industry/support/index.html.

Sincerely yours,

Mark N. McPherson

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

Enclosure

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KO52265 510(k) Number (if known):

Device Name: Competitor Duo Knee Femoral Components

Indications for Use:

The Competitor Duo 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 Competitor Duo Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.

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

Prescription Use × (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 of G. neral, Restorative, and Neurological Devices

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**510(k) Number** K052265