DEPUY SIGMA PS FEMORAL COMPONENTS

K073529 · DePuy Orthopaedics, Inc. · JWH · Jan 24, 2008 · Orthopedic

Device Facts

• Record ID: K073529
• Device Name: DEPUY SIGMA PS FEMORAL COMPONENTS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jan 24, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sigma PS Femoral Components are intended for cemented use as the femoral components of a Total Knee Replacement system. Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to significant improvement in their quality of life.

Device Story

Co-Cr-Mo alloy cruciate substituting femoral components for total knee replacement; asymmetric trochlear groove; available in sizes 1.5 to 6 (left/right). Features include optional fixation lugs/pegs, intercondylar box, and bolt hole for modular femoral stem attachment; supports modular augments on distal/posterior surfaces. Implanted by orthopedic surgeons in clinical settings; fixed to femur via bone cement. Device replaces damaged knee joint articulation to restore mobility and reduce pain. Benefit: improved quality of life for patients with severe joint degeneration.

Clinical Evidence

Bench testing only. Evidence includes dimensional comparisons, fatigue testing, and patellofemoral contact area analysis.

Technological Characteristics

Material: Co-Cr-Mo alloy. Design: Cruciate substituting femoral component with asymmetric trochlear groove. Fixation: Cemented. Features: Modular femoral stem attachment, optional lugs, modular augment compatibility. Dimensions: Sizes 1.5 to 6.

Indications for Use

Indicated for elderly patients with severe joint pain/disability due to osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant. May be used in younger patients if clinical benefits outweigh risks and activity/loading demands are limited. Suitable for patients with multiple joint involvement requiring improved mobility.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Darwin Knee System (K950010)
• PFC Sigma Knee System (K971189)

Submission Summary (Full Text)

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# K073529

## SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy Orthopaedics Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Establishment Registration No.: 1818910 | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------|
| 510(K) CONTACT: | Nancy Friddle<br>Project Manager, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone] | JAN 24 2008 |
| TRADE NAME: | DePuy Sigma PS Femoral Components | |
| COMMON NAME: | Total Knee System, Femoral Components | |
| CLASSIFICATION: | 888.3560 Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented<br>prosthesis; Class II | |
| PRODUCT CODE: | JWH | |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | Darwin Knee System, K950010<br>PFC Sigma Knee System (Size 1.5), K971189 | |

#### DEVICE DESCRIPTION:

The Sigma PS Femoral Components are part of the Sigma Total Knee Replacement System. They are Co-Cr-Mo alloy cruciate substituting femoral components with an asymmetric trochlear groove, available in sizes 1.5 to 6, in right and left versions. The Sigma PS Femoral Components are available with or without lugs (pegs) on the fixation surface. The femoral components incorporate an intercondylar box and bolt hole, which allow the attachment of optional femoral stems for additional stability. The Sigma PS Femoral Components (without lugs) allow for the attachment of modular augments on the distal and posterior fixation surfaces. Fixation of the femoral component to the femur is achieved using bone cement.

#### INTENDED USE:

The Sigma PS Femoral Components are intended for cemented use as the femoral components of a Total Knee Replacement system.

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Total Knee Replacement is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

#### INDICATIONS FOR USE:

Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to significant improvement in their quality of life.

#### BASIS FOR SUBSTANTIAL EQUIVALENCE:

The DePuy Sigma PS Femoral Components are a modification of the Sigma Femoral Components that were previously cleared as part of the Darwin Knee System (now called the Sigma Knee System) in K950010 and the PFC Sigma Knee System (now called the Sigma Knee System) in K971189. Based on similarities in indications, intended use, design, materials, method of manufacture and the results of dimensional comparisons, fatigue testing and patellofemoral contact area analysis, DePuy believes that the Sigma PS Femoral Components are substantially equivalent to the previously cleared femoral components.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a partial view of the Department of Health & Human Services (HHS) logo. The logo features the HHS emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the emblem.

Public Health Service

JAN 2 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Nancy S. Friddle Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, IN 46581-0988

Re: K073529

Trade/Device Name: DePuy Sigma PS Femoral Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: December 14, 2007 Received: December 17, 2007

Dear Ms. Friddle:

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 rcclassified 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. Nancy S. Friddle

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance At [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mulhearn

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 Statement

510(k) Number (if known): _ K073529

### Device Name: DePuy Sigma PS Femoral Components

The Sigma PS Femoral Components are intended for cemented use as the femoral components of a Total Knee Replacement system.

Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to significant improvement in their quality of life.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark M. Milken

(Division Sign-Off) (Division Sugaral, Bestorative, and Neurological Deveces

K07352°

310(k) Number