DEPUY SOLUTION SYSTEM HIP PROSTHESIS

K060581 · DePuy Orthopaedics, Inc. · LPH · May 19, 2006 · Orthopedic

Device Facts

• Record ID: K060581
• Device Name: DEPUY SOLUTION SYSTEM HIP PROSTHESIS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: May 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

DePuy Solution System® Hip Prosthesis is a femoral hip stem used in total hip arthroplasty. Device replaces damaged hip joint articulation to reduce pain and improve mobility. Implanted by orthopedic surgeons in clinical settings. Stem features Porocoat® sintered cobalt-chrome-molybdenum alloy bead porous coating for biological fixation (cementless) or augmentation of bone cement (cemented). Available in 10.5, 12.0, and 13.5 mm sizes. Device provides structural support for hip joint reconstruction.

Clinical Evidence

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

Technological Characteristics

Material: ASTM F-799 Forged Controlled-Carbon Cobalt-Chromium-Molybdenum alloy. Porous coating: Sintered cobalt-chrome-molybdenum alloy beads (Porocoat®). Form factor: Femoral hip stem, 10.5-13.5 mm sizes. Fixation: Cementless (biological ingrowth) or cemented. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to severe pain/disability from osteoarthritis, rheumatoid arthritis, traumatic arthritis, congenital hip dysplasia, avascular necrosis of femoral head, acute traumatic fracture of femoral head/neck, failed previous hip surgery, or ankylosis. Requires sufficient sound bone for component support. 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 Solution System® Hip Prostheses (K030979)
• Depuy Summit™ Cemented Hip Prosthesis (K013352)
• DePuy Vision Solution Hip Prosthesis (K953703)

Submission Summary (Full Text)

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Kobo581 page 1 of 2

Way 1 9 2005

# 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] |
| TRADE NAME: | DePuy Solution System® Hip Prosthesis |
| COMMON NAME: | Cementless or Cemented Porous Coated Hip Prosthesis |

#### CLASSIFICATION:

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

#### DEVICE PRODUCT CODE:

87 LPH

#### SUBSTANTIALLY EQUIVALENT DEVICES:

DePuy Solution System® Hip Prostheses (K030979, cleared April 24, 2003) Depuy Summit™ Cemented Hip Prosthesis (K013352, cleared December 17, 2001) DePuy Vision Solution Hip Prosthesis (K953703, cleared February 1, 1996)

### DEVICE DESCRIPTION:

The subject device, DePuy Solution System® Hip Prosthesis, is manufactured from ASTM F-799 Forged Controlled-Carbon Cobalt-Chromium-Molybdenum alloy and has a sintered cobaltchrome 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, 12.0 and 13.5 mm sizes.

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#### INTENDED USE:

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

### SUBSTANTIAL EQUIVALENCE:

Based on the same intended use, indications, sterilization method, packaging and design, DePuy believes that the Solution System® Hip Prosthesis is substantially equivalent to the FDA-cleared DePuy Solution System® Hip Prosthesis (K030979), the Vision Solution Hip Prosthesis (K953703) and the Depuy Summit™ Cemented Hip Prosthesis (K013352).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2006

DePuy Orthopaedics Inc. c/o Ms. Anne M. Schuler P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K060581

Trade/Device Name: Depuy Solution System® 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: April 14, 2006

Dear Ms. Schuler:

Received: April 19, 2006

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. Anne M. Schuler

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 (240) 276- 1020. 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,

Herbert Lerner ws

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): K06058/
Device Name: DePuy Solution System® 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 there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

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

The Solution System® Hip Stem is indicated for comentless use and 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.

Hulut Lemerico

Division of General, Restorative and Neurological Devices

**510(k) Number** Kol 0581

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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