DEPUY ASR TAPER SLEEVE ADAPTER

K070359 · DePuy Orthopaedics, Inc. · KWA · Mar 6, 2007 · Orthopedic

Device Facts

• Record ID: K070359
• Device Name: DEPUY ASR TAPER SLEEVE ADAPTER
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: Mar 6, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The subject taper sleeve adapters mate the femoral head to the femoral stem. This allows for a reduced number of femoral head components and offers various femoral head offsets and compatibility with multiple femoral stems. The subject device mates with all existing DePuy 11/13 and 12/14 stems.

Device Story

ASR Hip Taper Sleeve Adapter; mechanical component for total hip replacement. Functions as interface between femoral head and femoral stem; provides variable offsets to match patient anatomy; compatible with DePuy 11/13 and 12/14 femoral stems. Used by orthopedic surgeons in clinical/surgical settings. Enables modularity; reduces required inventory of femoral head components; facilitates reconstruction in patients with inadequate bone stock.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to predicate devices.

Technological Characteristics

Mechanical hip prosthesis component; taper sleeve adapter design; compatible with 11/13 and 12/14 femoral stems. Materials and design consistent with predicate systems.

Indications for Use

Indicated for total hip replacement in patients with severe pain/disability due to structural hip joint damage from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, nonunion of femoral fractures, congenital hip dysplasia, slipped capital femoral epiphysis, or disability from previous fusion where bone stock is inadequate.

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

• DePuy ASR™Modular Acetabular Cup System (K040627)
• DePuy Ultima Unipolar Head and Sleeve Adapters (K965156)

Submission Summary (Full Text)

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K070359

# 510 (k) Summary

(As required by 21 CFR 807.92 and 21 CFR 807.93)

MAR 0 6 2007

| NAME OF SPONSOR: | DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rhonda Myer Regulatory Affairs Telephone: [phone] Facsimile: [phone] Electronic Mail: [e-mail] |
| DATE PREPARED: | January 31, 2007 |
| PROPRIETARY NAME: | ASR™ Hip Taper Sleeve Adapter |
| COMMON NAME: | Femoral Hip Prosthesis |
| CLASSIFICATION: | Class III device per 21 CFR 888.3330: Hip Joint metal/metal semiconstrained, with an uncemented acetabular component prosthesis |
| DEVICE PRODUCT CODE: | 87 KWA |
| SUBSTANTIALLY EQUIVALENT DEVICES: | DePuy ASR™Modular Acetabular Cup System, K040627 DePuy Ultima Unipolar Head and Sleeve Adapters, K965156 |
| | |

## DEVICE DESCRIPTION:

The DePuy ASR Taper Sleeve Adapter mates with the ASR Femoral Heads (K040627) and any 11/13 or 12/14 DePuy femoral stem to provide differing offsets to best match the patient's anatomy.

## INTENDED USE AND INDICATIONS:

## Intended Use:

The subject taper sleeve adapters mate the femoral head to the femoral stem. This allows for a reduced number of femoral head components and offers various femoral head offsets and compatibility with multiple femoral stems. The subject device mates with all existing DePuy 11/13 and 12/14 stems.

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#### Indications for Use:

The DePuy ASR™ Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The substantial equivalence of the ASR Taper Sleeve Adapter is shown by its similarity in intended use, indications for use, materials and design to the existing DePuy ASR "" Modular Acetabular Cup System Sleeve Adapters, K040627 and the DePuy Ultima Unipolar Head and Sleeve Adapters, K965156.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc % Ms. Rhonda Myer Regulatory Associate, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46582

MAR 0 6 2007

Re: K070359 Trade/Device Name: ASR™ Hip Taper Sleeve Adapter Regulation Number: 21 CFR 888.3330 Regulation Name: Hip Joint metal/metal semi-constrained, with an uncemented acetabular component prosthesis Regulatory Class: III Product Code: KWA Dated: February 6, 2007 Received: February 7, 2007

Dear Ms. Myer:

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. Rhonda Myer

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/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

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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Image /page/4/Picture/0 description: The image shows the DePuy logo, which features a large black circle to the left of the word "DePuy" in a bold, sans-serif font. A horizontal line underlines the word. Below the line, the text "a Johnson & Johnson company" is written in a smaller, serif font. The logo is simple and professional, conveying a sense of stability and reliability.

DePuy Orthopaedics, Inc.

700 Orthopaedic Drive P.O. Box 988 Warsaw, IN 46581-0988 USA Tel: [phone] Fax: [phone]

# Indications for Use Statement

510 (k) Number (if known): _

K070359

Device Name: DePuy ASR™ Taper Sleeve Adapter

#### Indications for Use:

The DePuy ASR™ Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

X 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)

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(Division Sign-Off)
Division of Gereral, Restorative,
an iogical Devices

51 Number 16070353

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