DEPUY ASR RESURFACING FEMORAL HEADS

K032659 · DePuy Orthopaedics, Inc. · KXA · Dec 4, 2003 · Orthopedic

Device Facts

• Record ID: K032659
• Device Name: DEPUY ASR RESURFACING FEMORAL HEADS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KXA · Orthopedic
• Decision Date: Dec 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy ASR™ Resurfacing Femoral Heads are intended for cemented use in hemiarthroplasty (partial hip replacement procedure). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acctabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

Device Story

DePuy ASR Resurfacing Femoral Head is a one-piece cobalt-chromium-molybdenum (Co-Cr-Mo) metal implant; designed for hemi-arthroplasty to replace the articular surface of the femoral head. Device features a polished exterior and internal cavity for bone cement fixation; includes a short stem acting as a central guide pin. Used by orthopedic surgeons in clinical settings to treat femoral head pathology while preserving the patient's natural acetabulum. Implant replaces bone with a metal cap, allowing for minimal bone removal. Clinical benefit includes pain relief and restoration of function for patients with severe hip conditions where acetabular replacement is not indicated.

Clinical Evidence

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

Technological Characteristics

Material: Cobalt-chromium-molybdenum (Co-Cr-Mo) alloy. Design: One-piece metallic femoral head with internal cavity for bone cement and short stem guide pin. Sizes: 39mm range. Fixation: Cemented. Sterilization: Not specified.

Indications for Use

Indicated for patients with severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis requiring hemi-arthroplasty. Requires normal, non-deformed acetabular cavity.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.

Predicate Devices

• DePuy T.A.R.A Total Hip (K810325)
• Cemented Femoral Head Resurfacing Device (Biomet Orthopaedics, Inc.) (K021799)

Submission Summary (Full Text)

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DEC - 4 2003

K032659 page 14

## 510(k) Summary

| NAME OF FIRM: | DePuy Orthopaedics, Inc.<br>PO Box 988<br>700 Orthopaedics<br>Warsaw, IN 46581-0988 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Natalie Heck<br>Manager, Regulatory Affairs |
| TRADE NAME: | DePuy ASRTM Resurfacing Femoral Heads |
| COMMON NAME: | Resurfacing femoral head |
| CLASSIFICATION: | 888.3400: Hip joint femoral (hemi-hip) metallic<br>resurfacing prosthesis;<br>Class II |
| DEVICE PRODUCT CODE: | 87 KXA |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | DePuy T.A.R.A Total Hip, K810325<br>Cemented Femoral Head Resurfacing Device<br>(Biomet Orthopaedics, Inc.) K021799 |

#### DEVICE DESCRIPTION:

The DePuy ASR™ Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a onepiece cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm to suit varying patient anatomy.

The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the ninimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum.

#### INDICATIONS FOR USE:

The DePuy ASR™ Resurfacing Femoral Heads are intended for cemented use in hemiarthroplasty (partial hip replacement procedure). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acctabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

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## BASIIS OF SUBSTANTIAL EQUIVALENCE:

DePuy considers the DePuy ASR™ Resurfacing Femoral Heads to be substantially equivalent to
the femoral resurfacing heads submitted in the T.A.R.A. Total Hip Prosthesis, K.B.0 Biomet Cemented Femoral Resurfacing Head device, K. 1 Clair Homeons, Ruros22 And Inc. material composition, and intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 4 2003

Ms. Natalic Heck Manager, Regulatory Affairs DePuy Orthopedics, Inc. P.O. Box 988 700 Orthopedic Drive Warsaw, Indiana 46581

Re: K032659

Trade/Device Name: Depuy ASR™ Resurfacing Femoral Heads Regulation Number: 21 CFR 888.3400 Regulation Name: Hip Joint Femoral (Hemi-hip) Metallic Resurfacing Prosthesis Regulatory Class: Class II Product Code: KXA Dated: August 27, 2003 Received: September 5, 2003

Dear Ms. Heck:

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. Natalie Heck

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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Mark A. Millican

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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# 510(k) Number (if known): K6 3 > (3)

#### DePuy ASRTM Resurfacing Femoral Heads Device Name:

### Indications for Use:

The DePuy ASR™ Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

Concurrence of CDRH, Office of Device Evaluation

OR Prescription Use (Per 21 CFR/801.109)

Over-The-Counter Use

Mark N Millican

.ision Sign-Off) sion of General, Restorativ Ad Neurological Devices

K03 2659