DEPUY ASR MODULAR ACETABULAR CUP SYSTEM

K040627 · DePuy Orthopaedics, Inc. · KWA · Aug 5, 2005 · Orthopedic

Device Facts

• Record ID: K040627
• Device Name: DEPUY ASR MODULAR ACETABULAR CUP SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: Aug 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended 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.

Device Story

DePuy ASR Modular Acetabular Cup System is a metal-on-metal hip prosthesis for total hip replacement. System components include a one-piece cobalt-chrome molybdenum (CoCrMo) acetabular cup with Porocoat porous coating and hydroxyapatite (HA) coating, a unipolar CoCrMo femoral head, and a CoCrMo taper sleeve adapter. Device is implanted by orthopedic surgeons in a clinical/hospital setting. The prosthesis replaces the damaged hip joint, providing an articulating surface to restore joint function and alleviate pain. The system utilizes a modular design allowing for various neck lengths and head diameters to accommodate patient anatomy.

Clinical Evidence

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

Technological Characteristics

Materials: Cobalt-chrome molybdenum (CoCrMo) alloy. Surface: Porocoat porous coating with hydroxyapatite (HA). Components: One-piece acetabular cup (44-62mm), unipolar femoral head (39-55mm), and taper sleeve adapters (12/14 or 11/13 tapers). Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

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

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 Pinnacle Metal-on-Metal Acetabular Cup Line (K002883 & K003523)
• Wright Medical Metal TRANSCEND Articulation System (K021349)
• DePuy Ultima Unipolar Head and Adapter Sleeves (K965156)

Submission Summary (Full Text)

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# K040627

- AUG 5 2005
# 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 Modular Acetabular Cup System |
| COMMON NAME: | Femoral Hip Prosthesis |
| CLASSIFICATION: | Class III per 21 CFR 888.3330 Hip Joint<br>metal/metal semiconstrained, with an uncemented<br>acetabular component prosthesis |
| DEVICE PRODUCT CODE: | 87 KWA |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | DePuy Pinnacle® Metal-on-Metal Acetabular Cup<br>Line (K002883 & K003523)<br>Wright Medical Metal TRANSCEND® Articulation<br>System (K021349)<br>DePuy Ultima® Unipolar Head and Adapter Sleeves<br>(K965156) |

## DEVICE DESCRIPTION:

The DePuy ASR™ Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter.

The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy onepiece cup with Porocoat® porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups.

The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy The femoral heads articulate with corresponding one-piece metal 12/14 or 11/13 tapers. acetabular cups.

The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima" Unipolar Head and Adapter

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K040627 (pg 2 of 2)

Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12.

#### 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:

DePuy believes the DePuy ASR™ Modular Acetabular Cup System to be substantially equivalent to the DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners; the Wright Medical Metal TRANSCEND Articulation System; and the DePuy Ultima Adapter Sleeves based upon the similarities in design, material composition, and intended use/indications for use.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive PO Box 988 Warsaw, Indiana 46581-0988

Re: K040627

Trade/Device Name: DePuy ASRTM Modular Acetabular Cup System 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: May 23, 2005 Received: May 24, 2005

AUG 5 - 2005

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. Iisting 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. Natalie Heck

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,

Hupfhurdu

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): _ h040627 510(K) Number (II Known): "ITV
Device Name: DePuy ASR ™ Modular Acetabular Cup System

## Indications for Use:

The DePuy ASR™ Modular Acetabular Cup System is indicated for use in 101aLhip replacement The Del as for patients suffering severe pain and disability due to structural damage in the hip joint from theumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, John "Hour" thoumatord" and nonunion of femoral fractures. Use of the prosthesis is also indicated for a valients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Posted November 13, 2003)

Hypl Rurlis

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

KO 40627 519(k) Number