ADVANCE SPIKED POROUS TIBIAL BASE

K063128 · Wrightmedicaltechnologyinc · MBH · Mar 21, 2007 · Orthopedic

Device Facts

• Record ID: K063128
• Device Name: ADVANCE SPIKED POROUS TIBIAL BASE
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MBH · Orthopedic
• Decision Date: Mar 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ADVANCE® Spiked Porous Tibial Base is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: - noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1) avascular necrosis; - 2) inflammatory degenerative joint disease including rheumatoid arthritis; - 3) correction of functional deformity: - revision procedures where other treatments or devices have failed; and 4) - treatment of fractures that are unmanageable using other techniques. ર) The ADVANCE® Spiked Porous Tibial Base is for use without bone cement and is a single use device.

Device Story

ADVANCE® Spiked Porous Tibial Base is a prosthetic component for knee arthroplasty; intended for uncemented fixation. Device features 4 spikes on distal surface for stability; available with or without screw holes. Manufactured from titanium alloy with titanium porous coating. Used by orthopedic surgeons in clinical settings during knee replacement procedures. Provides mechanical support for joint reconstruction; facilitates bone ingrowth via porous coating. Single-use device.

Clinical Evidence

Bench testing only.

Technological Characteristics

Titanium alloy construction; titanium porous coating; 4-spike distal geometry; available with/without screw holes; uncemented fixation; single-use.

Indications for Use

Indicated for skeletally mature patients undergoing knee arthroplasty for pain relief or functional improvement due to noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, revision of failed treatments, 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.

Submission Summary (Full Text)

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K063128

### MAR 2 1 2007 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® Spiked Porous Tibial Base.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | October 11, 2006 |
| Contact Person: | Theresa Leister |
| | Regulatory Affairs Specialist II |
| Proprietary Name: | ADVANCE® Spiked Porous Tibial Base |
| Common Name: | Tibial Base |
| Classification Name and Reference: | 21 CFR 888.3565 Prosthesis, Knee,<br>Patello/femorotibial, Semi-Constrained,<br>Uncemented, Porous Coated,<br>Polymer/Metal/Polymer - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/MBH |

#### DEVICE INFORMATION

#### A. INTENDED USE

The ADVANCE® Spiked Porous Tibial Base is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1) avascular necrosis;
- 2) inflammatory degenerative joint disease including rheumatoid arthritis;
- 3) correction of functional deformity:
- revision procedures where other treatments or devices have failed; and 4)
- treatment of fractures that are unmanageable using other techniques. ર)

The ADVANCE® Spiked Porous Tibial Base is for use without bone cement and is a single use device.

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# B. DEVICE DESCRIPTION

The design features of the ADVANCE® Spiked Porous Tibial Base are described below.

- 4 spikes on the distal surface .
- . Available with or without screw holes
- Manufactured from titanium alloy .
- Titanium porous coating .

The design features of ADVANCE® Spiked Porous Tibial Base are substantially equivalent to the design features of other devices previously cleared for market.

# C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the ADVANCE® Spiked Porous Tibial Base are substantially equivalent to previously cleared predicate devices. The safety and effectiveness of the ADVANCE® Spiked Porous Tibial Base is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Ms. Theresa Leister Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

MAR 2 1 2007

Re: K063128

Trade/Device Name: ADVANCE Spiked Porous Tibial Base Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH Dated: March 8, 2007 Received: March 9, 2007

Dear Ms. Leister:

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 - Ms. Theresa Leister

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 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,

Oarbara Bneelus

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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# Indications for Use

510(k) Number (if known):

K063128

Device Name: ADVANCE® Spiked Porous Tibial Base

Indications For Use:

The ADVANCE® Spiked Porous Tibial Base is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

- noninflammatory degenerative joint disease including osteoarthritis, traumatic 1) arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis; 2)
- correction of functional deformity; 3)
- revision procedures where other treatments or devices have failed; and 4)
- 5) treatment of fractures that are unmanageable using other techniques.

The ADVANCE® Spiked Porous Tibial Base is for use without bone cement and is a single use device.

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)

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Barbara Buelup

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

510(k) Number K063128