ADVANCE A-CLASS TIBIAL INSERT

K081479 · Wrightmedicaltechnologyinc · MBH · Feb 20, 2009 · Orthopedic

Device Facts

• Record ID: K081479
• Device Name: ADVANCE A-CLASS TIBIAL INSERT
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MBH · Orthopedic
• Decision Date: Feb 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ADVANCE A-CLASS Tibial Insert is indicated for use with the Advance Total Knee system in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis 2) inflammatory degenerative joint disease including rheumatoid arthritis: 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed: and 5) treatment of fractures that are unmanageable using other techniques. The ADVANCE A-CLASS Insert is for single use: The Advance Total Knee System porous components are for use without bone cement. The Advance Total Knee System non-porous components are for use with bone cement.

Device Story

The ADVANCE A-CLASS Tibial Insert is a single-use orthopedic component designed for use with the Advance Total Knee system. It features a medial pivot rotation articulating surface and a perimeter capture locking mechanism with a central dovetail. Constructed from cross-linked GRU1020 UHMWPE, the insert is available in sizes 1-6 with thicknesses ranging from 10mm to 25mm. It is intended for implantation by orthopedic surgeons in clinical settings to address joint pain and functional impairment. The device functions as a bearing surface within the total knee arthroplasty construct, facilitating joint movement and stability. It is compatible with both cemented (non-porous) and uncemented (porous) components of the Advance Total Knee System.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Cross-linked GRU1020 UHMWPE. Design: Medial pivot rotation articulating surface; perimeter capture lock with central dovetail. Sizes: 1-6; thickness: 10mm-25mm. Single-use. Compatible with cemented and uncemented knee system components.

Indications for Use

Indicated for skeletally mature patients undergoing knee arthroplasty for noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity correction, revision procedures, or unmanageable fractures.

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

• ADVANCE Medial Pivot Tibial Insert
• LINEAGE A-CLASS Acetabular Liner

Submission Summary (Full Text)

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FEB 2 0 2009

# 1081479

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the ADVANCE® A-CLASS® Tibial Base '

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Wright Medical Technology, Inc.

May 9, 2008

Fred W. Bowman, P.E.

Senior Regulatory Affairs Specialist

#### ADVANCE® A-CLASS® Insert

Tibial Insert

21 CFR 888.3560 Knee, Patellofemorotibial, Semiconstrained, cemented, Polymer/ metal/polymer

21 CFR 888.3565 Knee, patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

Device Product Code and Panel Code:

Orthopedics/87/ JWH Orthopedics/87/ MBH

#### DEVICE INFORMATION

## A. INTENDED USE

The ADVANCE A-CLASS Tibial Insert is indicated for use with the Advance Total Knee system in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1) noninflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis

- 2) inflammatory degenerative joint disease including rheumatoid arthritis:
- correction of functional deformity; 3)
- 4) revision procedures where other treatments or devices have failed: and
- 5) treatment of fractures that are unmanageable using other techniques.

The ADVANCE A-CLASS Insert is for single use: The Advance Total Knee System porous components are for use without bone cement. The Advance Total Knee System non-porous components are for use with bone cement.

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# B. DEVICE DESCRIPTION

The design features of the ADVANCE® A-CLASS® Tibial Insert are summarized below:

- Articulating Surface: Medial Pivot rotation
- Lock Detail: Perimeter capture with central dove tail .
- Size Range: Sizes 1-6, thicknesses of 10mm-25mm .
- Material: Cross-Linked GRU1020 UHMWPE ●

# C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features of the ADVANCE® A-CLASS® Tibial Insert are substantially equivalent to the design features, excluding material, of the ADVANCE® Medial Pivot Tibial Insert. The material of the ADVANCE® A-CLASS® Tibial Insert is substantially equivalent to the material of the LINEAGE® A-CLASS® Acetabular Liner.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains an image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Mr. Fred W. Bowman. P.E. Senior Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K081479

Trade/Device Name: ADVANCE® A-CLASS Tibial Insert

Regulation Number: 21 CFR 888,3565

Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis

FEB 2 0 2009

Regulatory Class: II Product Code: MBH, JWH Dated: January 30, 2009 Received: February 2, 2009

Dear Mr. Bowman:

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

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Page 2 - Mr. Fred W. Bowman, P.E.

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 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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

For
mo
N.V.
2/26/05

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radioingical Health -

Enclosure

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# Indications for Use

510(k) Number (if known):

#### Device Name: ADVANCE® A-CLASS Tibial Insert

Indications For Use:

The ADVANCE A-CLASS Tibial Insert is indicated for use with the Advance Total Knee system in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1) noninflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis

- 2) inflammatory degenerative joint disease including rheumatoid arthritis:
- 3) correction of functional deformity;
- 4) revision procedures where other treatments or devices have failed: and
- 5) treatment of fractures that are unmanageable using other techniques.

The ADVANCE A-CLASS Insert is for single use. The Advance Total Knee System porous components are for use without bone cement. The Advance Total Knee System non-porous components are for use with bone cement.

Prescription Use XXX (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)

1 of 1

(Division Sign-Off) Division of General. Restorative. and Neurological Devices

**510(k) Number** k081479