SADDLE SHAPED PATELLA

K993371 · Wrightmedicaltechnologyinc · JWH · Dec 20, 1999 · Orthopedic

Device Facts

• Record ID: K993371
• Device Name: SADDLE SHAPED PATELLA
• Applicant: Wrightmedicaltechnologyinc
• Product Code: JWH · Orthopedic
• Decision Date: Dec 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for use in total 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® Saddle Shaped Patella is for use with bone cement only.

Device Story

ADVANCE® Saddle Shaped Patella is an all-polyethylene tibial component for total knee arthroplasty; product line extension to ADVANCE® Knee System. Device articulates with medial pivot femoral component; provides increased surface area and improved articulation. Available in 3 sizes with 25mm diameter. Intended for use with bone cement only. Implanted by orthopedic surgeons in clinical/hospital settings to reduce pain and improve knee function.

Clinical Evidence

Bench testing only. Mechanical test data demonstrated that the device exceeds requirements for contact area and lateral stability compared to other currently available knee systems.

Technological Characteristics

Material: UHMWPE (ASTM F 648). Form factor: Saddle-shaped patellar component, 25mm diameter, 3 sizes. Fixation: Bone cement. Energy source: None (mechanical implant).

Indications for Use

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

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• ADVANCE Total Knee System Patella

Submission Summary (Full Text)

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DEC 2 0 1999

<99337 /

## 510(k) Summary

Company: Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 Date: October 6, 1999 Trade Name: ADVANCE® Saddle Shaped Patella Common Name: All polyethylene tibial component Predicate Device: ADVANCE Total Knee System Patella

Description/Intended Use:

The ADVANCE® Saddle Shaped Patella is manufactured from UHMWPE (ASTM F 648). The patella is designed to be a product line extension to the existing ADVANCE® Knee System.

It is designed to articulate with the surface geomery of the medial pivot femoral component. The design of the subject device provides better articulation and increased surface area. The patella is available in 3 sizes, that match the articulating geometry of the femoral component. All three patellae have the same diameter of 25mm.

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

The ADVANCE® Saddle Shaped Patella is for use with bone cement only.

The Saddle Shaped Patella was declared substantially equivalent to the predicate devices. Mechanical test data demonstrated that it exceeds the requirements for contact area and lateral stability compared to other knees currently available.

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DEC 2 0 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lynne Witkowski Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K993371 Trade Name: ADVANCE® Saddle Shaped Patella Regulatory Class: II Product Code: JWH Dated: October 6, 1999 Received: October 7, 1999

Dear Ms. Witkowski:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Lynne Witkowski

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Neil R.P., Ogden for
James E. Dillard III

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K993371

| 510(k) Number (if known) | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | ADVANCE® Saddle Shaped Patella |
| Indications for Use | <p> <b>Intended Use</b> </p> <p> Indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: </p> <p> 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; </p> <p> 2) inflammatory degenerative joint disease including rheumatoid arthritis; </p> <p> 3) correction of functional deformity; </p> <p> 4) revision procedures where other treatments or devices have failed; and </p> <p> 5) treatment of fractures that are unmanageable using other techniques. </p> <p> The ADVANCE® Saddle Shaped Patella is for use with bone cement only. </p> |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (per 21 CFR 801.109) | OR Over-The Counter Use |
|-----------------------------------------|-------------------------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K993371 |