HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS

K032479 · Howmedica Osteonics Corp. · JWH · Sep 4, 2003 · Orthopedic

Device Facts

• Record ID: K032479
• Device Name: HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
• Applicant: Howmedica Osteonics Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Sep 4, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the new Tibial Tray Screw Hole Plug is the same as that of the predicate device described in premarket notification K970779 -- to occlude all tibial tray screw holes not occupied by bone screws. The Tibial Tray Screw Hole Plugs are factory assembled to the tibial tray screw holes. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw. By occluding the tibial tray screw holes, the Tibial Tray Screw Hole Plugs helps prevent intrusion of bone cement onto the tibial tray.

Device Story

Tibial tray screw hole plugs; used in knee arthroplasty. Factory-assembled to tibial tray; surgeon removes plugs from holes requiring bone screws intraoperatively. Plugs occlude remaining holes to prevent bone cement intrusion onto the tibial tray. Device serves as a physical barrier during cemented prosthesis implantation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Ultra high molecular weight polyethylene (UHMWPE). Design: Tapered with flat bottom, lip, and flat top surface. Function: Mechanical occlusion of tibial tray screw holes. Non-powered, passive implant component.

Indications for Use

Indicated for occlusion of unused tibial tray screw holes in patients undergoing knee joint replacement surgery to prevent bone cement intrusion.

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

• Osteonics Tibial Tray Screw Hole Plugs (K970779)

Submission Summary (Full Text)

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K032479

Line Extension to Howmedica Osteonics Tibial Tray Screw Hole Plugs

Special 510(k) Premarket Notification

#### Special 510(k) Summary

Proprietary Name:

Common Name:

Classification Name and Reference:

Proposed Regulatory Class: Device Product Code:

Predicate Proprietary Name: Predicate Regulatory Class: Predicate Product Code:

For Information contact:

Howmedica Osteonics Tibial Tray Screw Hole Plugs Tibial Tray Screw Hole Plugs

Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis 21 CFR §888.3560 and Cement Obturator

Class II 87 JWH and LZN

Osteonics Tibial Tray Screw Hole Plugs Class II 87 JWH and LZN

Margaret F. Crowe Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401-1677 Phone: [phone] Fax: [phone]

### Description/Technological Comparison

The subject Tibial Tray Screw Hole Plugs are a line extension to the existing Howmedica Osteonics Tibial Tray Screw Hole plugs found substantially equivalent in premarket notification K970779. The predicate Tibial Tray Screw Hole Plugs are fabricated from low-density polyethylene, and are circular in design. The subject Tibial Tray Screw Hole Plugs are manufactured from ultra high molecular weight polyethylene, and incorporate a tapered design, with a flat bottom with a lip, tapering to a flat top surface.

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K032479

Line Extension to Howmedica Osteonics Tibial Tray Screw Hole Plugs

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## Intended Use

The intended use of the new Tibial Tray Screw Hole Plug is the same as that of the predicate device described in premarket notification K970779 -- to occlude all tibial tray screw holes not occupied by bone screws. The Tibial Tray Screw Hole Plugs are factory assembled to the tibial tray screw holes. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw. By occluding the tibial tray screw holes, the Tibial Tray Screw Hole Plugs helps prevent intrusion of bone cement onto the tibial tray.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677

Re: K032479

Trade/Device Name: Line Extension - Howmedica Osteonics Tibial Tray Screw Hole Plugs Regulation Number: 21 CFR 888.3560

Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis and cement obturator

Regulatory Class: II Product Code: JWH, LZN Dated: August 8, 2003 Received: August 12, 2003

Dear Ms. Crowe:

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.

SEP = 4 2003

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Page 2 - Ms. Margaret F. Crowe

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 yours,

Mach n Milbersen

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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# 510(k) Number (if known): _K032479

## Device Name: Line Extension - Howmedica Osteonics Tibial Tray Screw Hole Plugs

The subject Tibial Tray Screw Hole Plugs are intended to occlude all tibial tray screw holes not occupied by bone screws. The Tibial Tray Screw Hole Plugs are factory assembled to the tibial tray screw holes. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw. By occluding the tibial tray screw holes, the Tibial Tray Screw Hole Plugs help prevent intrusion of bone cement onto the tibial tray.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use (Pcr 21 CFR 801.109) (Optional Format 1-2-96)

Mark N Millican

Division of General, Restorative and Neurological Devices

510(k) Number K032479