GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE

K033351 · Global Orthopaedic Technology, USA, Inc. · HRY · Mar 11, 2004 · Orthopedic

Device Facts

• Record ID: K033351
• Device Name: GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE
• Applicant: Global Orthopaedic Technology, USA, Inc.
• Product Code: HRY · Orthopedic
• Decision Date: Mar 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Global Resurfacing Unicompartmental (GRU) Knee System is intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial conclyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single-use implant that is intended for use with bone cement.

Device Story

Global Resurfacing Unicompartmental (GRU) Knee System is a semi-constrained, cemented, metal/polymer knee prosthesis. System comprises anatomic femoral component (cobalt chrome alloy) and semi-lunar tibial component (UHMWPE). Femoral component features central keel and post for cement fixation and rotational stability; requires left/right specific geometries. Tibial component features universal geometry. Device is single-use implant for surgical replacement of articulating knee surfaces. Intended for use by orthopedic surgeons in clinical settings to address compartmental degenerative disease or trauma. Benefits include restoration of joint function and reduction of pain associated with localized knee joint pathology.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Cobalt chrome alloy (ASTM F-75-01) for femoral component; ultra-high molecular weight polyethylene (UHMWPE) (ASTM F-648-00) for tibial component. Design: Semi-constrained, cemented, metal/polymer prosthesis. Femoral component: anatomic, left/right specific, central keel/post. Tibial component: semi-lunar, universal geometry.

Indications for Use

Indicated for patients requiring partial knee replacement due to compartmental primary degenerative disease, post-traumatic degenerative disease, previous tibial condyle or plateau fractures, joint deformity, or revision of previous arthroplasty where only one side of the joint is affected.

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).

Submission Summary (Full Text)

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K03351

MAR 1 1 2004

## SUMMARY OF SAFETY AND EFFECTIVENESS

- Global Orthopaedic Technology USA, Inc. Sponsor: 5349 Fled Leaf Court Oviedo, Florida 32765
Global Resurfacing Unicompartmental Knee System Device:

Classification Name: Knee Joint, Femorotibial, Metal/Polymer, Semi-constrained, Cemented Prosthesis (21 CFR 888.3530)

Intended Use: Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single-use implant intended for implantation with bone cement.

Device Description: The Global Resurfacing Unicompartmental Knee System consists of femoral and tibial components.

The femoral component is anatomic in design, to provide coverage of the condyle from posterior to anterior. The anatomic shape of the femoral component necessitates separate left and right geometries. A central keel and post on the back of the femoral component assists in cement fixation and rotational stability. The device is manufactured from cobalt chrome alloy that conforms to ASTM F-75-01.

The tibial component is semi-lunar in configuration and manufactured from compression molded ultra-high molecular weight polyethylene (UHMWPE) that conforms to ASTM F-648-00. The tibial component is universal in geometry.

Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:

Reaction to bone cernent Deformity of the joint Cardiovascular disorders Fracture of bone cement Implant loosening/migration Nerve damage

Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Bone fracture Infection Hematoma Dislocation Excessive wear

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 2004

Mr. Carl Knobloch Chief Operating Officer Global Orthopaedic Technology, USA, Inc. 5349 Red Leaf Court Oviedo, Florida 32765

Re: K033351

Trade/Device Name: Global Resurfacing Unicompartmental (GRU) Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: February 16, 2004 Received: February 17, 2004

Dear Mr. Knobloch:

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 - Mr. Carl Knobloch

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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark N. Millman

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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Confidential

## Indications for Use

510(k) Number (if known): K033351

Device Name: Global Resurfacing Unicompartmental (GRU) Knee System

Indications For Use: The Global Resurfacing Unicompartmental (GRU) Knee System is intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial conclyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single-use implant that is intended for use with bone cement.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Do

Mullins

Division of General, Restorative, and Neurological Devices

**510(k) Number** K033351

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