SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS

K061569 · Smith & Nephew, Inc. · NPJ · Jul 6, 2006 · Orthopedic

Device Facts

• Record ID: K061569
• Device Name: SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS
• Applicant: Smith & Nephew, Inc.
• Product Code: NPJ · Orthopedic
• Decision Date: Jul 6, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Competitor Deuce Femoral Components are orthopedic implants designed to replace medial condyle and patellofemoral regions of femoral knee joint. Device addresses conditions requiring more than single-compartment treatment. Implants are single-use, intended for fixation with bone cement. Used by orthopedic surgeons in clinical/surgical settings to restore joint function and alleviate pain associated with arthritis or failed prior procedures. Benefit to patient includes improved joint mobility and reduction of symptoms in affected knee compartments.

Clinical Evidence

Bench testing only. Mechanical and clinical data review indicated equivalence to currently used devices and capability to withstand expected in vivo loading without failure.

Technological Characteristics

Femoral knee prosthesis components. Materials: Cobalt chrome and Oxinium. Fixation: Bone cement. Design: Semiconstrained, patellofemorotibial. Single-use.

Indications for Use

Indicated for patients with knee conditions requiring treatment of both medial condyle and patellofemoral regions, including post-traumatic arthritis, degenerative arthritis, and failed osteotomies, hemiarthroplasties, or unicompartmental replacements. For use with bone cement only.

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

• Hybrid Knee Femoral (K042896)
• Competitor Duo Knee Femoral Component (K052265)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

# Smith & Nephew Competitor Deuce Femoral Components

Contact Person and Address

Date of Summary: June 28, 2006

Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116 1901) 399-5520

JUL - 6 2006

Name of Device: Competitor Deuce Femoral Components Common Name: Knee Prosthesis

## Device Description

The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint. The Competitor Deuce femoral components will initially be available in both cobalt chrome and Oxinium. The overall design of the Competitor Deuce femoral components is based upon the existing Hybrid Knee femoral components and Competitor Duo femoral components subject of K042896 and K052265, respectively.

#### Device Classification

21 CFR 888.3560 Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis - Class II

#### Mechanical and Clinical Data

A review of the mechanical and clinical data indicated that the Competitor Deuce femoral components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.

#### Intended Use

The Competitor Deuce 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:

.

- 트 Post-traumatic arthritis;
- a Degenerative arthritis: and
- Failed osteotomies, hemiarthroplasties; and unicompartmental replacement 트

These indications will be used for the Competitor Deuce femoral components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.

The Competitor Deuce femoral components are single use only and are intended for implantation only with bone cement.

## Substantial Equivalence Information

The Smith & Nephew Competitor Deuce femoral components are similar to the following commercially available devices regarding design features, overall indications, and materials;

- Smith & Nephew, Inc. Hybrid Knee Femoral (K042896) 트
- Smith & Nephew Competitor Duo Knee Femoral Component (K052265) ■

510(k) Summary.doc

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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 the department's emblem, which consists of a stylized caduceus-like symbol with three human profiles facing right. The emblem is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 2006

Mr. Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116

Re: K061569

> Trade/Device Name: Competitor Deuce Femoral Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: NPJ Dated: June 28, 2006 Received: June 29, 2006

Dear Mr. Sells:

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. I isting 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 devise can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. IDA max 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 not he Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Jason Sells

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. 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Taiba Buehner
Mark N. Mellekerson, M.S.

Mark N. Melker 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): KOG 1569

Device Name: Competitor Deuce Femoral Components

Indications for Use:

The Competitor Deuce 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; t
- 트 Degenerative arthritis; and
- Failed osteotomies, hemiarthroplasties; and unicompartmental replacement 트

These indications will be used for the Competitor Deuce femoral components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.

The Competitor Deuce femoral components are single use only and are intended for implantation only with bone cement.

Prescription Use x AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oa. bar. Suclp

Division of General, Restorative, and Neurological Devices

510(k) Number K061569

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Indications.doc