RBK PATELLA FEMORAL KNEE

K050473 · Global Orthopaedic Technology, USA, Inc. · KRR · Nov 14, 2005 · Orthopedic

Device Facts

• Record ID: K050473
• Device Name: RBK PATELLA FEMORAL KNEE
• Applicant: Global Orthopaedic Technology, USA, Inc.
• Product Code: KRR · Orthopedic
• Decision Date: Nov 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RBK Patella Femoral Knee is intended for use in treating patients with osteoarthritis in the distal femur and patella, patients with a history of patellar fracture and those patients with failed previous surgery where pain, deformity or dysfunction persists. The device is a singleuse implant that is intended for use with bone cement.

Device Story

RBK Patella Femoral Knee System; semi-constrained cemented prosthesis for knee joint replacement. System comprises anatomic cobalt chrome femoral component (ASTM F-75-01) with four fixation pegs and circular, domed UHMWPE patellar component (ASTM F-648-00). Implanted by surgeons in clinical setting to address osteoarthritis, fracture, or failed prior surgery. Device provides mechanical articulation to restore joint function and reduce pain. Single-use implant; requires bone cement for fixation.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design and material characteristics.

Technological Characteristics

Materials: Cobalt chrome alloy (ASTM F-75-01) for femoral component; compression molded UHMWPE (ASTM F-648-00) for patellar component. Design: Semi-constrained, cemented. Femoral component features four fixation pegs; patellar components available in 24mm-40mm diameters. Energy source: None (mechanical).

Indications for Use

Indicated for patients with osteoarthritis of the distal femur and patella, history of patellar dislocation or fracture, or failed previous surgery resulting in pain, deformity, or dysfunction. Intended for use with bone cement.

Regulatory Classification

Identification

A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. 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 a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” (vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and (viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and (viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”

Submission Summary (Full Text)

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K050473

## SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor: Global Orthopaedic Technology USA. Inc. 5349 Red Leaf Court Oviedo, Florida 32765

Device: RBK Patella Femoral Knee System

Classification Name: Knee Joint Patellofemoral Polymer/Metal Semi-constrained Cemented Prosthesis - Class II (21 CFR 888.3540)

Intended Use: The RBK Patella Femoral Knee is intended for use in treating patients with osteoarthritis in the distal femur and patella, patients with a history of patellar fracture and those patients with failed previous surgery where pain, deformity or dysfunction persists. The device is a singleuse implant that is intended for use with bone cement.

Device Description: The RBK Patella Femoral Knee System consists of femoral and patellar components.

The femoral component is anatomic in design, to provide coverage of the condyles from posterior to anterior. The anatomic shape of the femoral component necessitates separate left and right geometries. A group of four pegs (posts) 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 patella components are offered in one configuration; circular, domed, all UHMWPE. The polymer components are manufactured from compression molded ultra-high molecular weight polyethylene (UHMWPE) that conforms to ASTM F-648-00. The domed, all poly patella buttons are available in 5 diameters (24mm - 40mm).

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 cement 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2005

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

Re: K050473

Trade/Device Name: RBK Patella Femoral Knee System Regulation Number: 21 CFR 888.3540 Regulation Name: Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis Regulatory Class: II Product Code: KRR Dated: November 4, 2005 Received: November 7, 2005

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- Carl Knobloch, M.Sc.

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/industry/support/index.html.

Sincerely yours.

Barbara Buchund
for

Mark N. Melkerson Acting 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): K050473

Device Name: RBK Patella Femoral Knee System

Indications for Use:

The RBK Patella Femoral Knee is intended for use in treating patients with osteoarthritis in The NDR Patella i emoral Nith a history of patellar dislocation or patellar fracture the distal formal und putfailed previous surgery where pain, deformity or dysfunction and those patients with failou provious carger) in the is intended for use with bone cement.

X Prescription Use (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 Device Evaluation (ODE)

Barbara Buehrig

Division of General, Restorative. and Neurological Devices

**510(k) Number** K050473