DEPUY SIGMA CR-F FEMORAL COMPONENT

K082500 · DePuy Orthopaedics, Inc. · JWH · Nov 18, 2008 · Orthopedic

Device Facts

• Record ID: K082500
• Device Name: DEPUY SIGMA CR-F FEMORAL COMPONENT
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Nov 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an uncquivocal 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. The Sigma CR-F femoral component is intended to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knec flexion.

Device Story

The DePuy Sigma CR-F femoral component is a Co-Cr-Mo orthopedic implant designed for total knee replacement. It features an asymmetric trochlear groove, textured fixation surface, and two pegs for stability with recessed cement pockets. Used in clinical settings by orthopedic surgeons, the device replaces damaged knee joint articulation to reduce pain and improve mobility. It is specifically designed to accommodate high knee flexion up to 150 degrees. The component is implanted via cemented fixation. It benefits patients by restoring joint function and quality of life, particularly in cases of severe arthritis or failed prior implants.

Clinical Evidence

No clinical data. Substantial equivalence determined via non-clinical bench testing, including tibiofemoral contact area and pressure analysis, range of motion analysis, and constraint testing.

Technological Characteristics

Material: Co-Cr-Mo alloy. Design: Asymmetric trochlear groove, textured fixation surface, two pegs, recessed cement pockets. Sizes: 1.5-6 (left/right). Fixation: Cemented only. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring total knee replacement due to severely painful and/or disabled joints resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implants. Intended for cemented use only.

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

• PFC Sigma® Knee System (cleared as Darwin Knee System) (K943462)
• PFC Cruciate Retaining Knee System, Size 1.5 (K96168)

Submission Summary (Full Text)

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KD82500 * 1/2

## 510(k) Summary

# NOV 1 8 2008

| Applicant / Sponsor: | DePuy Orthopaedics Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Establishment Registration No.: 1818910 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Nancy Friddle<br>Project Leader, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone] |
| Proprietary Name: | DePuy Sigma CR-F femoral component |
| Common Name: | Total Knee Replacement Prosthesis |
| Classification Name: | 21 CFR 888.3560: Knee joint patellofemorotibial,<br>polymer/metal/polymer semi-constrained cemented<br>prosthesis, Class II |
| Product Code: | JWH |
| Substantially<br>Equivalent Devices: | PFC Sigma® Knee System (cleared as Darwin Knee<br>System), K943462 |
| | PFC Cruciate Retaining Knee System, Size 1.5, K96168 |

## Device Description:

The Sigma CR-F femoral component is part of the PFC Sigma Total Knee Replacement System. It is a Co-Cr-Mo femoral component with an asymmetric trochlear groove, available in sizes 1.5 - 6, in right and left versions. The fixation surface is textured. It incorporates two pegs to provide additional stability and recessed cement pockets for enhanced cement fixation. These features have not changed from those on the predicate PFC Sigma CR femoral component.

## Intended Use:

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.

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Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an uncquivocal 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.

The Sigma CR-F femoral component is intended to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knec flexion.

### Indications:

The DePuy Sigma CR-F femoral component is intended for cemented use only.

Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, theumatoid arthritis, or a failed previous implant.

#### Summary of Technologies/Substantial Equivalence:

The Sigma CR-F femoral component has the same indications, materials, manufacturing process, sterilization and packaging as the previously cleared PFC Sigma CR femoral components. The design of the implant has been modified to provide more congruent articulation with the tibial insert during high flexion.

#### Non-Clinical Testing:

Comparisons of tibiofemoral contact area and pressure, range of motion analysis and constraint testing were performed to demonstrate the substantial equivalence of the Sigma CR-F femoral components to the predicate PFC Sigma CR femoral components.

#### Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the subject Sigma CR-F femoral components and the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in providing health and human services to the people of the United States.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Nancy Friddle Project Leader, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

NOV 1 8 2008

K082500 Trade/Device Name: DePuy Sigma Cr-F Femoral Component Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: August 28, 2008 Received: August 29, 2008

Dear Ms. Friddle:

Re:

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, Or to 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 devise can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA0000 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 af 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. Nancy Friddle

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliary, pat [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 Protmarket, Surveillance at [phone]. For questions regarding the reporting 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 vours.

Mark M. Mulhausen

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): _ (082500

Device Name: DePuy Sigma CR-F Femoral Component

Indications for Use:

The DePuy Sigma CR-F femoral component is intended for cemented use only.

Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

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)

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Division of General, Restorative, and Neurological Devices

**510(k) Number** K682500