DEPUY AML HIP PROSTHESIS

K061833 · DePuy Orthopaedics, Inc. · LPH · Jul 17, 2006 · Orthopedic

Device Facts

• Record ID: K061833
• Device Name: DEPUY AML HIP PROSTHESIS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jul 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Depuy AML® Hip Prosthesis is intended for use in total hip arthroplasty (THA) in either a cementless or cemented application. Total hip arthroplasy is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Device Story

DePuy AML® Hip Prosthesis is a femoral hip stem component for total hip arthroplasty. Device manufactured from forged cobalt-chromium-molybdenum alloy (ASTM F-799) with sintered cobalt-chrome molybdenum alloy bead porous coating (Porocoat®) on the stem surface. Designed for either cementless fixation via biological tissue ingrowth or cemented fixation where porous coating augments bone cement bond. Available in 10.5 mm and 12.0 mm sizes. Used by orthopedic surgeons in clinical/hospital settings to replace damaged hip joint articulation, aiming to reduce pain and restore patient mobility. Device provides structural support for hip joint replacement.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Material: Forged cobalt-chromium-molybdenum alloy (ASTM F-799). Coating: Sintered cobalt-chrome molybdenum alloy bead porous coating (Porocoat®). Fixation: Cementless (biological ingrowth) or cemented. Sizes: 10.5 mm and 12.0 mm. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to severe pain/disability from osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of femoral head, acute traumatic fracture of femoral head/neck, failed previous hip surgery (reconstruction, fixation, arthrodesis, hemiarthroplasty, surface replacement), or ankylosis. Suitable for cementless use (biological tissue ingrowth) or cemented use.

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

• DePuy AML® Hip Prosthesis (K012364)
• DePuy Solution System® Hip Prosthesis (K060581)
• DePuy Vision Solution Hip Prosthesis (K953703)

Submission Summary (Full Text)

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JUL 17 2006

# SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy Orthopaedics Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>EST REG No.. 1818910 |
|-----------------|--------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Anne Schuler<br>Sr Regulatory Affairs Associate<br>Tel: [phone]<br>Fax: [phone] |
| DATE PREPARED: | June 26, 2006 |
| TRADE NAME: | DePuy AML® Hip Prosthesis |
| COMMON NAME: | Cementless or Cemented Porous Coated Hip Prosthesis |

### CLASSIFICATION:

21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis, Class II Device

### DEVICE PRODUCT CODE: 87 LPH

#### SUBSTANTIALLY EQUIVALENT DEVICES:

DePuy AML® Hip Prosthesis (K012364, cleared October 19, 2001) DePuy Solution System® Hip Prosthesis (K060581, cleared May 19, 2006) DePuy Vision Solution Hip Prosthesis (K953703, cleared February 1, 1996)

#### DEVICE DESCRIPTION:

The subject device, DePuy AML® Hip Prosthesis, is manufactured from ASTM F-799 Forged Controlled-Carbon Cobalt-Chromium-Molybdenum alloy and has a sintered cobalt-chrome molybdenum alloy bead porous coating (Porocoat@) applied to the stem. The porous coating is applied to the entire stem with the exception of the tapered stem tip region. The stems are available in 10.5 and 12.0 mm sizes.

## INTENDED USE:

The Depuy AML® Hip Prosthesis is intended for use in total hip arthroplasty (THA) in either a cementless or cemented application. Total hip arthroplasy is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

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## SUBSTANTIAL EQUIVALENCE:

Based on the same intended use, indications, sterilization method, packaging and design, DePuy believes that the AML® Hip Prosthesis is substantially equivalent to the FDA-cleared DePuy AML® Hip Prosthesis (K012364), the Solution System® Hip Prosthesis (K060581) and the Vision Solution® Hip Prosthesis (K953763).

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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 the department's name encircling a stylized caduceus symbol. The caduceus is represented by a staff with intertwined snakes, a symbol often associated with medicine and healthcare. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2006

DePuy Orthopaedics, Inc. % Ms. Anne M. Schuler Sr. Regulatory Affairs Associate P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K061833

Trade/Device Name: Depuy AML® Hip Prosthesis 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: June 28, 2006 Received: June 30, 2006

Dear Ms. Schuler:

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. Anne M. Schuler

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" (21 CFR 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

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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# Indications for Use

510(k) Number (if known): Device Name: DePuy AML® Hip Prosthesis

Indications for Use:

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where ts evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

- 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- 3. Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. 5.

The AML® Hip Stem is indicated for cementless use with fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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Verhare Budrund for *MKM*

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

| 510(k) Number | K061833 |
|---------------|---------|
|---------------|---------|

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