MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38

K063414 · Encore Medical L.P. · KWA · Dec 12, 2006 · Orthopedic

Device Facts

• Record ID: K063414
• Device Name: MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38
• Applicant: Encore Medical L.P.
• Product Code: KWA · Orthopedic
• Decision Date: Dec 12, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The FMP Metal/Metal Acetabular Insert used in total hip 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

FMP Metal/Metal Acetabular Insert is a semiconstrained hip prosthesis component. Modification involves changing the porous coating process of acetabular shells from a two-layer to a three-layer process, utilizing smaller bead and pore sizes. Device is intended for surgical implantation in total hip replacement procedures. It functions as a mechanical component of the hip joint system. Clinical benefit includes restoration of joint function and treatment of degenerative or traumatic hip conditions. Used by orthopedic surgeons in clinical/hospital settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material comparability.

Technological Characteristics

Semiconstrained metal-on-metal acetabular insert for uncemented hip prosthesis. Features a three-layer porous coating on acetabular shells with reduced bead and pore size compared to the previous two-layer design. Classified under 21 CFR 888.3330 (Product Code KWA).

Indications for Use

Indicated for patients requiring total hip replacement due to degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, failed prior treatments/devices, or nonunion/fractures of the proximal femur with head involvement.

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).

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

Y063414

JEC 1 2 2006

Date: November 9, 2006

Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758

Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: Teffany Hutto(@encoremed.com Trade Name: FMP Metal/Metal Acetabular Insert

Common Name: Prosthesis, hip, semiconstrained

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

Description: The modification to the system consists of a change in the method or porous coating of the acetabular shells from a two layer process to a three layer process utilizing a smaller bead size and smaller pore size.

Intended Use: The FMP Metal/Metal Acetabular Insert used in total hip 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 the same materials, design, indications, packaging, labeling, and sterilization,

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, bold line drawing style.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2006

Encore Medical, L.P. % Ms. Teffany Hutto Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758

Re: K063414 Trade/Device Name: FMP Metal/Metal Acetabular Insert Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA Dated: November 9, 2006 Received: November 21, 2006

Dear Ms. Hutto:

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, 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 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 - Ms. Teffany Hutto

forth in the quality systems (OS) 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 yours,

Jaibarg Rnechup

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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510(k) Number (if known):

Device Name: FMP Metal/Metal Acetabular Insert

Indications for Use:

## FMP Metal/Metal Acetabular Insert Indications for Use

Indications for use in total hip replacement include: 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.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joubare Buehurs for MGM
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K063414

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