SPECTRUM MODULAR SYSTEM

K033893 · DePuy Orthopaedics, Inc. · LPH · Mar 12, 2004 · Orthopedic

Device Facts

• Record ID: K033893
• Device Name: SPECTRUM MODULAR SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Mar 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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: 1. A 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, surface hemiarthroplasty, and arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. This device is intended for single use.

Device Story

Spectrum Modular System is a three-piece, uncemented femoral hip prosthesis; components include proximal body, distal stem, and locking nut. Modular design allows independent positioning of proximal and distal components; available in various lengths and diameters. Used in total hip arthroplasty to replace damaged hip joint articulation; intended to increase patient mobility and reduce pain. Implanted by orthopedic surgeons in clinical/hospital settings. Device provides structural replacement for femoral hip joint; benefits patient through restoration of joint function and pain relief.

Clinical Evidence

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

Technological Characteristics

Three-piece uncemented femoral hip prosthesis; modular design with interchangeable proximal bodies and distal stems. Materials and specific ASTM standards not detailed in provided text. Mechanical fixation via uncemented porous-coated interface. No software or electronic components.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to osteoarthritis, traumatic/rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, acute traumatic fracture, failed previous hip surgery, or ankylosis, provided sufficient sound bone exists to support components.

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

• Titan Porocoat Hip Prosthesis (K001991)
• Malory Head Modular Calcar (K001660)
• ZMR Hip System Revision Taper (K992667)
• Link Mp Reconstruction Hip (K955296)

Submission Summary (Full Text)

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K033893 page 17

MAR 1 2 2004

# 510(k) Summary

| Name of Sponsor: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Est. Reg. No. 1818910 | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 510(k) Contact: | Dina L. Weissman, J.D.<br>Legal Consultant, Regulatory Affairs<br><br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] | |
| Trade Name: | Spectrum Modular System | |
| Common Name: | Femoral Hip Joint Uncemented Prosthesis | |
| Classification: | Class II device per 21 CFR 888.3358:<br>Hip joint metal/polymer semi-constrained<br>uncemented prosthesis | |
| Device Product Code: | 87LPH Hip joint metal/polymer semi-<br>constrained uncemented prosthesis | |
| | No performance standards have been established<br>under Section 514 of the Federal Food, Drug,<br>and Cosmetic Act for femoral hip stems. | |
| Substantially Equivalent Devices: | Titan Porocoat Hip Prosthesis | K001991 |
| | Malory Head Modular Calcar | K001660 |
| | ZMR Hip System Revision Taper | K992667 |
| | Link Mp Reconstruction Hip | K955296 |
| Device Descriptions: | The Spectrum Modular System is a three-piece,<br>uncemented femoral hip prosthesis consisting of<br>a proximal body, a distal stem and a locking nut.<br>The proximal bodies and distal stems are<br>interchangeable, allowing each to be<br>independently positioned. They are available in<br>a variety of proximal body lengths, distal body<br>diameters and lengths. The system is | |

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## 510(k) Summary (continued)

#### 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:

- 1. A 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, surface hemiarthroplasty, and arthroplasty, or total hip replacement.
- 5. Certain cases of ankylosis.

#### Substantial equivalence:

The Spectrum Modular System uncemented femoral hip prosthesis has the same intended use and basic design as the predicate devices and is therefore substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of three human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Diana L. Weissman, J.D. Depuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedics Drive Warsaw, Indiana 46581-0988

Re: K033893 Trade/Device Name: Spectrum Modular System 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: December 15, 2003 Received: December 16, 2003

MAR 1 2 2004

Dear Ms. Weissman:

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. Diana L. Weissman, J.D.

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 vours.

Sincerely yours,

L. Mark A. McMillan

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): Ko 3 S89 3

## Device Name: Spectrum Modular System

### 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:

- 1. A 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 arthroplasty, or total hip replacement.
- 5. Certain cases of ankylosis.

This device is intended for single use.

Concurrence of CDRH, Office of Device Evaluation

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

Division of General, R. storative, and Neurological Devices

**510(k) Number** K033893