FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38

K070221 · Encore Medical L.P. · KWA · Apr 4, 2007 · Orthopedic

Device Facts

• Record ID: K070221
• Device Name: FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
• Applicant: Encore Medical L.P.
• Product Code: KWA · Orthopedic
• Decision Date: Apr 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

Joint replacement is indicated for patients suffering from disability due to: - noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; - rheumatoid arthritis; - correction of functional deformity; - femoral fracture; This device may also be indicated in the salvage of previously failed surgical attempts.

Device Story

Metal/metal hip prosthesis system consisting of acetabular inserts and hip system components. Used for total hip replacement surgery to restore joint function. Implanted by orthopedic surgeons in clinical/hospital settings. Device replaces natural femoral head and acetabulum to address degenerative disease, arthritis, deformity, or fracture. Provides structural support and articulation for hip joint. No software or electronic components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Metal/metal hip prosthesis; semi-constrained; uncemented acetabular component. Materials, design, and sterilization methods are identical to predicate devices.

Indications for Use

Indicated for patients with disability due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or femoral fracture; also indicated for salvage of failed surgical attempts.

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

Date: January 23, 2007

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

Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: Teffany [e-mail] Trade Name: FMP™ Metal/Metal Acetabular Insert

Common Name: Acetabular Insert

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

Description: The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.

Intended Use: Joint replacement is indicated for patients suffering from disability due to:

- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
- . rheumatoid arthritis;
- . correction of functional deformity:
- femoral fracture; .

This device may also be indicated in the salvage of previously failed surgical attempts.

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

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### Summary of Safety and Effectiveness

Date: January 23, 2007

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

Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: Teffany [e-mail] Trade Name: Metal/Metal Hip System

Common Name: Total Hip Prosthesis, Semi-Constrained

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

The modification consists of a change to the Instructions for Use to minimize the Description: necessity for multiple IFU's and to update the contents to reflect current practice.

Intended Use: Joint replacement is indicated for patients suffering from disability due to:

- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
- rheumatoid arthritis; .
- correction of functional deformity; .
- . femoral fracture;

This device may also be indicated in the salvage of previously failed surgical attempts.

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

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# Summary of Safety and Effectiveness

Date: January 23, 2007

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

Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: Teffany [e-mail] Trade Name: CLP® Offset Total Hip System

Common Name: Total Hip Prosthesis, Semi-Constrained

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

Description: The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.

Intended Use: Joint replacement is indicated for patients suffering from disability due to:

- . noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- . rheumatoid arthritis;
- . correction of functional deformity;
- femoral fracture; ●

This device may also be indicated in the salvage of previously failed surgical attempts.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

APR 4 - 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K070221

Trade/Device Name: FMP™ Metal/Metal Acetabular Insert; Metal/Metal Hip System; CLP® Offset Total Hip System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with uncemented acetabular component, prosthesis Regulatory Class: Class III Product Codes: KWA, JDI, KWL, KWY, KWZ, LPH, LWJ, LZO Dated: January 23, 2007 Received: January 24, 2007

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 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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Page 2 - Ms. Teffany Hutto

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.

Валере Внекитр

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:

### FMPTM Metal/Metal Acetabular Insert Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
- rheumatoid arthritis; .
- correction of functional deformity; .
- femoral fracture; .

This device may also be indicated in the salvage of previously failed surgical attempts.

Prescription Use X (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)

Barbara Neelup

ision Sign-9 Division of General, Restorative, and Neurological Devices

**510(k) Number** K070221

Page 1 of 1

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510(k) Number (if known):

Device Name: Metal/Metal Hip System

Indications for Use:

### Metal/Metal Hip System Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

- · noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis; .
- correction of functional deformity; .
- femoral fracture; .

This device may also be indicated in the salvage of previously failed surgical attempts.

Prescription Use X (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)

Page 1 of 1

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CLP® Offset Total Hip System

Indications for Use:

#### CLP® Offset Total Hip System Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
- rheumatoid arthritis; .
- correction of functional deformity; .
- femoral fracture; .

This device may also be indicated in the salvage of previously failed surgical attempts.

Prescription Use X (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)