MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS

K030979 · DePuy Orthopaedics, Inc. · LPH · Apr 24, 2003 · Orthopedic

Device Facts

• Record ID: K030979
• Device Name: MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Apr 24, 2003
• 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 in either a cementless (by biological tissue ingrowth into the porous coating) or cemented application (in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement). 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.

Device Story

The DePuy Solution System Hip Prosthesis is a single-use femoral hip component. It is implanted by orthopedic surgeons during total hip arthroplasty to replace damaged hip joint articulation. The device is manufactured from cobalt-chromium-molybdenum alloy and features a sintered porous coating (Porocoat) on the stem to facilitate biological tissue ingrowth (cementless) or to augment fixation in bone cement (cemented). The polished neck and tapered stem tip remain uncoated. By replacing the damaged joint, the device aims to reduce pain and improve patient mobility. It is intended for patients with sufficient bone stock to support the implant.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use similarities.

Technological Characteristics

Material: ASTM F-75 Cobalt Chromium-Molybdenum alloy. Surface: Sintered cobalt-chrome-molybdenum alloy bead porous coating (Porocoat). Design: Femoral stem with polished neck and tapered tip. Fixation: Cemented or cementless (biological ingrowth).

Indications for Use

Indicated for patients requiring total hip arthroplasty due to severely painful/disabled joints from osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement, or total hip replacement), or ankylosis. Requires sufficient sound bone to seat and support components. Used for cementless fixation via biological tissue ingrowth or cemented fixation.

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 Vision Solution Hip Prosthesis (K953703)
• DePuy AML Hip Prosthesis (K012364)

Submission Summary (Full Text)

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K030979

K030979

NAME OF SPONSOR: DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Est. Reg. No. 1818910 510(K) CONTACT: Karla A. Ham Senior Regulatory Associate Phone: [phone] FAX: [phone] DePuy Solution System Hip Prosthesis TRADE NAME: COMMON NAME: Cemented or cementless porous-coated hip prosthesis CLASSIFICATION: Class II Device per 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis DEVICE PRODUCT CODE: 87LPH SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Vision Solution Hip Prosthesis, K953703 DePuy AML Hip Prosthesis, K012364

#### DEVICE DESCRIPTION:

510(k) Summary

The DePuy Solution System Hip Prosthesis is manufactured from ASTM F-75 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 polished neck and tapered stem tip region. The DePuy Solution System Hip Prosthesis is a single use device.

#### INTENDED USE AND INDICATIONS:

The DePuy Solution System Hip Prosthesis is intended for use in total hip arthroplasty in either a cementless (by biological tissue ingrowth into the porous coating) or cemented application (in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement). 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:

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

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# 510(k) Summary (cont.)

### BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on similarities of design, same materials, identical sterilization processes, and the same intended use, DePuy believes that the modified DePuy Solution System Hip Prosthesis is substantially equivalent to the previously cleared Vision Hip Prosthesis (K953703) and the DePuy AML Hip Prosthesis (K012364).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three birds in flight, arranged in a row. The birds are facing to the right. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the birds.

Public Health Service

APR 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karla A. Ham Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581

Re: K030979

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: II Product Code: LPH Dated: March 25, 2003 Received: March 28, 2003

Dear Ms. Ham:

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. Karla A. Ham

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 N Milkusen

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): Ko20979

#### DePuy Solution System® Hip Prosthesis Device Name:

## 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 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, theumatoid arthritis, or 1. congenital hip dysplasia.
- 2. Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck. 3.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, ব surface replacement arthroplasty, or total hip replacement.
- న్. Certain cases of ankylosis.

The DePuy Solution System Hip System is indicated for cementless 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.

Concurrence of CDRH, Office of Device Evaluation

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

510(k) Number. K030979

Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)