DEPUY GCK TIBIAL COMPONENTS

K070267 · DePuy Orthopaedics, Inc. · HRY · Aug 17, 2007 · Orthopedic

Device Facts

• Record ID: K070267
• Device Name: DEPUY GCK TIBIAL COMPONENTS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HRY · Orthopedic
• Decision Date: Aug 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sigma High Performance Unity Knee Resurfacing System 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.

Device Story

Sigma High Performance Unity Knee Resurfacing System is a modular knee prosthesis consisting of femoral, patellofemoral, tibial, and patellar components. Used for unicompartmental, bicompartmental, or tricompartmental knee replacement. Components are implanted by orthopedic surgeons in a clinical setting to replace damaged articular surfaces. System provides increased mobility and pain reduction. Metal-backed tibial components utilize wrought forged Co-Cr-Mo trays and cross-linked UHMWPE inserts. All components require bone cement for fixation. Device benefits patients by restoring joint function in cases of arthritis, gout, or pseudogout.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench testing, including engineering analysis, wear simulator testing, and mechanical testing.

Technological Characteristics

System components include wrought forged Co-Cr-Mo tibial trays and XLK cross-linked UHMWPE tibial inserts. Modular design allows various combinations for uni-, bi-, or tricompartmental replacement. Cemented fixation only. No software or electronic components.

Indications for Use

Indicated for single or multicompartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces, or history of gout or pseudogout. Cemented use only.

Regulatory Classification

Identification

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

Predicate Devices

• DePuy GCK (K061648)
• DePuy Preservation Unicondylar Knee (K040268)
• DePuy Sigma Unicompartmental Knee (J&J PFC Unicondylar Knee System) (K910968)

Submission Summary (Full Text)

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# 3. 510(K) SUMMARY

| Applicant / Sponsor: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Establishment Registration No.: 1818910 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Nancy Friddle<br>Team Leader, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone] |
| Proprietary Name: | Sigma High Performance Unity Knee Resurfacing<br>System |
| Common Name: | Compartmental Knee Prosthesis System |
| Classification Name: | 21 CFR 888.3530: Knee joint femorotibial,<br>metal/polymer semi-constrained cement prosthesis, Class<br>II |
| Product Codes: | HRY, NPJ |
| Substantially<br>Equivalent Devices: | DePuy GCK (K061648) |
| | DePuy Preservation Unicondylar Knee (K040268) |
| | DePuy Sigma Unicompartmental Knee, submitted as the<br>J&J PFC Unicondylar Knee System (K910968) |

# Device Description:

The Sigma High Performance Unity Knee Resurfacing System is composed of unicompartmental femoral components, patellofemoral trochlear components, unicompartmental tibial components and patellar components. These components may be used in various combinations to create: a single unicompartmental femorotibial replacement for either the medial or lateral side of the knee; two unicompartmental femorotibial replacements for both the medial and lateral sides of the knee; a patellofemoral replacement; a bicompartmental patellofemorotibial replacement for the medial or lateral side of the knee; or a tricompartmental patellofemorotibial replacement for the medial and lateral sides of the knee.

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# K070267

This submission adds metal-backed unicompartmental tibial components to the previously cleared GCK System. The Sigma High Performance Unity Knee Resurfacing System metalbacked unicompartmental tibial components consist of wrought forged Co-Cr-Mo unicompartmental tibial trays and XLK cross-linked UHMWPE unicompartmental tibial inserts. The trays and inserts are available in 6 sizes and in left medial / right lateral and right medial / left lateral configurations. Each tibial insert is available in 5 thicknesses. The Sigma High Performance Unity Knee Resurfacing System metal-backed unicompartmental tibial components are intended for use with the previously cleared GCK unicompartmental femoral components.

#### Intended Use:

The Sigma High Performance Unity Knee Resurfacing System 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:

The Sigma High Performance Unity Knee Resurfacing System is indicated for single or multicompartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All Sigma High Performance Unity Knee Resurfacing System components are intended for CEMENTED USE ONLY.

## Summary of Technologies/Substantial Equivalence:

The Sigma High Performance Unity Knee Resurfacing System metal-backed unicompartmental tibial components have the same indications and intended use, a similar design and the same articulating geometry as the previously cleared GCK all polyethylene unicompartmental tibial The manufacturing materials are identical to materials that have been components. previously cleared in other DePuy knee prostheses.

#### Non-Clinical Testing:

Engineering analysis, wear simulator testing and mechanical testing were performed to demonstrate the substantial equivalence of the Sigma High Performance Unity Knee Resurfacing System mctal-backed unicompartmental tibial components to the predicate devices.

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# Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the subject Sigma High Performance Unity Knee Resurfacing System Tibial Components and the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract representation of a human figure or a symbol related to health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

AUG 1 7 2007

K070267 Trade/Device Name: Sigma High Performance Unity Knee Resurfacing System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY, NPJ Dated: May 23, 2007 Received: May 25, 2007

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. 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 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 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 yours,

Barbara Schneider Romm

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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# 2. INDICATIONS FOR USE

510(k) Number (if known): _ \ 0 7 0 26 7

Device Name: Sigma High Performance Unity Knee Resurfacing System

Indications for Use:

The Sigma High Performance Unity Knee Resurfacing System is indicated for single or multi-compartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All Sigma High Performance Unity Knee Resurfacing System components are intended for CEMENTED USE ONLY.

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)

Barbara Buchanan

Page 1 of 1

Division of General, Restorative, and Neurological Devices

510(k) Number_K070267