FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM

K072154 · Encore Medical L.P. · LPH · Dec 14, 2007 · Orthopedic

Device Facts

• Record ID: K072154
• Device Name: FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM
• Applicant: Encore Medical L.P.
• Product Code: LPH · Orthopedic
• Decision Date: Dec 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Encore Medical hip devices are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use. While hip replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

Device Story

Total hip arthroplasty system components including acetabular liners, shells, and femoral heads; modification involves transition of acetabular liner material from UHMWPe to highly cross-linked UHMWPe; includes size additions to existing product line. Used in orthopedic surgery for joint replacement; intended to restore mobility and reduce pain in patients with degenerative joint disease or fracture. Cementless application only.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design comparison.

Technological Characteristics

Acetabular system components; materials include highly cross-linked UHMWPe (modified from standard UHMWPe) and metal; cementless fixation; semi-constrained prosthesis.

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. For cementless use only.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Foundation® (FMPTM) Porous Coated Spiked Acetabular System (K974093)
• Foundation® (FMPTM) Porous Coated Hemispherical Acetabular System (K974095)
• Foundation® (FMPTM) Porous Coated Flared Rim Acetabular System (K973119)
• Foundation® Press Fit (Porous Coated) Hip Stem (K973302)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

Date: December 10, 2007

DEC 1 4 2007

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

Contact Person: Teffany Hutto Manger, Regulatory Affairs Phone: [phone] Fax: [phone] Email: Teffany [e-mail]

| Product | 510(k) Number, Clearance Date, Classification | Product Code | Product Code | Regulation and Classification Name |
|-------------------------------------------------------------------|-----------------------------------------------|--------------|--------------|--------------------------------------------------------------------------------------------------------|
| Foundation® (FMPTM) Porous Coated Spiked Acetabular System | K974093, January 28, 1998, Class II | LPH | LPH | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis per 21 CFR 888.3358 |
| Foundation® (FMPTM) Porous Coated Hemispherical Acetabular System | K974095, January 28, 1998, Class II | LPH | | |
| Foundation® (FMPTM) Porous Coated Flared Rim Acetabular System | K973119, January 28, 1998, Class II | LPH | | |
| Foundation® Press Fit (Porous Coated) Hip Stem | K973302 - December 2, 1997, Class II | LPH | | |

The modification consists of a change to Encore Medical's acetabular liner to from Description: UHMWPe to highly cross-linked UHMWPe. Additionally, this application addresses a size addition to Encore Medical's current acetabular liners, acetabular shells, and femoral heads.

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. It is to be used for cementless applications only.

Intended Use - Encore Medical hip devices are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use. While hip replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

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

DEC 1 4 2007

Re: K072154 Trade/Device Name: Foundation® (FMP™) Porous Coated Acetabular System (Spiked, Hemispherical, Flared Rim) and Foundation® Press Fit (Porous Coated) Hip Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: December 6, 2007 Received: December 7, 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

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Mark N Mulkerson

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): K072154

Device Name: Acetabular System

Indications for Use:

## FMP™ Acetabular System (Spiked, Hemispherical, Flared Rim) Foundation® Porous Coated Hip Stem

## 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. It is to be used for cementless applications only.

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)

Poto Amm

(Division Sign Division of General, Restorative, and Neurological Devices

510(k) Number L072154