DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS

K062654 · DePuy Orthopaedics, Inc. · MBH · Sep 29, 2006 · Orthopedic

Device Facts

• Record ID: K062654
• Device Name: DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Sep 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sigma Cruciate Retaining Porocoat Femoral Components are intended for cemented or cementless use as the femoral components of a Total Knee Replacement system. 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. 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

Sigma C/R Porocoat Femoral Components are Co-Cr femoral implants for total knee replacement; feature asymmetric trochlear groove; available in sizes 1.5-6 (left/right). Designed for cemented or cementless fixation (biologic tissue ingrowth into porous coating). Used by orthopedic surgeons in clinical settings to replace damaged knee joint articulation. Benefits include increased patient mobility and reduced pain. Device serves as a structural replacement component; no electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material identity to predicate devices.

Technological Characteristics

Co-Cr femoral components with Porocoat porous coating for cementless or cemented fixation. Asymmetric trochlear groove design. Sizes 1.5-6. Class II device.

Indications for Use

Indicated for patients requiring total knee replacement due to osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant. Applicable to elderly patients with severe joint pain/disability and selected younger patients with unequivocal clinical need and limited activity demands. Requires sufficient sound bone for component seating.

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Predicate Devices

• PFC Sigma Knee System (K943462)
• PFC Cruciate Retaining Knee System (K961685)
• AML Proximally Coated Hip (K933787)

Reference Devices

• LCS Knee Femoral Components (P830055)

Submission Summary (Full Text)

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K062654

## SEP 2 9 2006

#### 510(k) SUMMARY

| 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>Team Leader, Regulatory Affairs<br>Tel: [phone]<br>Email: [e-mail] |
| TRADE NAME: | DePuy Sigma Cruciate Retaining (C/R)<br>Porocoat® Femoral Components |
| COMMON NAME: | Total Knee Replacement Prosthesis |
| CLASSIFICATIONS: | 888.3560 Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained<br>cemented prosthesis; Class II<br>888.3565 Knee joint patellofemorotibial<br>polymer/metal porous coated uncemented<br>prosthesis; Class II |
| DEVICE PRODUCT CODES: | JWH, MBH |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | PFC Sigma® Knee System (cleared as Darwin<br>Knee System), K943462<br>PFC Cruciate Retaining Knee System, Size 1.5<br>K961685<br>AML® Proximally Coated Hip, K933787 |

## DEVICE DESCRIPTION:

The Sigma C/R Porocoat Femoral Components are part of the Sigma Total Knee Replacement System. They are porous coated Co-Cr femoral components with an asymmetric trochlear groove, available in sizes 1.5- 6, in right and left versions. Fixation of the femoral component to the femur is achieved using either bone cement or by biologic fixation via tissue ingrowth into the porous coating.

## INDICATIONS FOR USE:

The Sigma C/R Porocoat Femoral Components are intended for cemented or cementless 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 bv replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

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.

### SUBSTANTIAL EQUIVALENCE

The Sigma C/R Porocoat Femoral Components are identical in design to the Sigma Femoral Components cleared for cemented use only in K943462 and K961685. The Porocoat porous coating of the Sigma C/R Porocoat Femoral Components is identical to the Porocoat porous coating used on the LCS Knee Femoral Components, which were approved for cementless use in P830055 and on the AML Proximally Coated Hip cleared for cementless use in K933787.

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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 features an abstract eagle-like symbol with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

SEP 2 9 2006

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

Re: K062654

Trade/Device Name: "DePay Sigma Cruciate Retaining Porocoat" Femoral Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: September 6, 2006 Received: September 7, 2006

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 for about in 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. Nancy 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 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 from the Division of Small Manufacturers, International and Consumer Assistance at its will ber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

f
Mark N. Mulkerson

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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K062654 510(k) Number (if known):

Device Name: DePuy Sigma Cruciate Retaining Porocoat® Femoral Components

Indications for Use:

The Sigma Cruciate Retaining Porocoat Femoral Components are intended for cemented or cementless use as the femoral components of a Total Knee Replacement system.

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.

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) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)

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and Neurslogica

**510(k) Number** K062654

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