METAL/METAL HIP SYSTEM

K040354 · Encore Medical L.P. · KWA · Nov 4, 2004 · Orthopedic

Device Facts

• Record ID: K040354
• Device Name: METAL/METAL HIP SYSTEM
• Applicant: Encore Medical L.P.
• Product Code: KWA · Orthopedic
• Decision Date: Nov 4, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Metal/Metal Hip System used in total hip replacement is intended for conditions of degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.

Device Story

Metal/Metal Hip System is a semi-constrained total hip prosthesis; consists of metal femoral heads and acetabular cup assembly. Acetabular cup features metal shell, polyethylene liner, and metal articulating inlay. Device components are implanted by orthopedic surgeons in clinical settings to replace diseased or damaged hip joints. System provides structural support and articulation for patients with degenerative joint disease, rheumatoid arthritis, or proximal femur fractures. Size range includes 48mm-66mm shells and 28mm-38mm femoral heads/inlays. Device functions as a mechanical replacement for the hip joint; clinical benefit is restoration of joint function and mobility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Polyethylene liner (ISO 5834-2), metal components (ASTM F799). Design: Semi-constrained total hip prosthesis with uncemented acetabular component. Dimensions: Shells 48mm-66mm (2mm increments); articulating components 28mm, 32mm, 34mm, 38mm. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring total hip replacement due to degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, revision of failed prior treatments, or nonunion/fractures of the proximal femur (femoral neck/trochanteric) where other techniques are unmanageable.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip 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 and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Predicate Devices

• K003250

Submission Summary (Full Text)

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K040354

NOV - 4 2004

EXHIBIT Ib

## Summary of Safety and Effectiveness

Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758 512-832-9500

Trade Name: Metal/Metal Hip System

Common Name: Total Hip Prosthesis, Semi-constrained

Classification Name: Hip joint metal/metal semi-constrained with an uncemented acetabular component prosthesis, 21CFR 888.3330

Description: The metal/metal hip system consists of metal femoral heads and an acetabular cup. The acetabular cup is a metal shell with a polyethylene liner that has a machined feature to accept a metal articulating inlay. The polyethylene components are manufactured from materials conforming to ISO 5834-2 and the metal components are manufactured from materials conforming to ASTM F799. The design features of these parts are identical to those previously cleared under K003250.The metal shells are available with outside diameters of 48mm to 66mm (in 2mm increments). The shells accept a nolyethylene liner with a metal articulating inlay with inner diameters of 28mm, 32mm, 34mm, and 38mm. The femoral heads are available in diameters of 28mm, 32mm, 34mm, and 38mm. The size changes referenced in this 510(k) are the additional 32mm, 34mm, and 38mm components.

Intended Use: The Metal/Metal Hip System used in total hip replacement is intended for conditions of degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.

Comparable Features to Predicate Device(s): Features comparable to predicate devices include same materials, design, and indications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 2004

Ms. Debbie De Los Santos Supervisor, Regulatory/Clinical Affairs Encore Medical L.P. 9800 Metric Boulevard Austin, Texas 78758

Re: K040354

Trade/Device Name: Metal/Metal Hip System Regulation Number: 21 CFR 888.3330 Kegulation Name: 21 OFFC 8061535 Regulation Name: Hip joint metal metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA Dated: October 5, 2004 Received: October 6, 2004

Dear Ms. De Los Santos:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass blated in the enactment date of the enactment date of the Medical Device Amendments, or to conimered processified 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, 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 he 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 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I ma letter watification. The FDA finding of substantial equivalence of your device to a legally premaince medicate 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 it you assno operate 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 Macer Eacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Millman

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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## Indications for Use

## :510 (k) Number (if known): K040354"

Device Name: Metal/Metal Hip System

Indications for Use:

Indications for use in total hip replacement include: degenerative joint disease including mulcations for use in total mp replass theumatoid arthritis; correction of functional osteoarthritis and avasoalar necrested other treatments or devices have failed; and delorminy, revision procedures where ond trochanteric fractures of the proximal femur ucatifient of nonanced, which is unmanageable using other techniques.

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)

Mark A. Melhusso

Sion- F Division of General, Restorative, and Neurological Devices

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**510(k) Number** K040354