EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM

K050766 · Zimmer Trabecular · HWE · May 26, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050766
• Device Name: EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
• Applicant: Zimmer Trabecular
• Product Code: HWE · General, Plastic Surgery
• Decision Date: May 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Explant™ Osteonecrosis Intervention Implant Removal Kit is intended for removal of a Trabecular Metal™ Osteonecrosis Intervention Implant.

Device Story

Explant™ Osteonecrosis Intervention Implant Removal Kit consists of sterile, single-use surgical instruments designed for implant removal. Kit includes 10mm and 14mm ID coring tubes; 10mm tube requires concurrent use of 14mm tube. Instruments feature preassembled Zimmer Hudson Fitting Adaptors for attachment to Zimmer T-Handle or Zimmer Power Driver. Hudson fittings are removable to allow access to a through-hole for specimen extraction from the coring tube. Used by surgeons in clinical/OR settings to facilitate removal of osteonecrosis intervention implants. Device provides mechanical means for coring and extracting implants, aiding surgical revision procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparison.

Technological Characteristics

Single-use surgical instrument kit. Includes 10mm and 14mm ID coring tubes. Features Zimmer Hudson Fitting Adaptors for manual (T-Handle) or powered (Zimmer Power Driver) operation. Includes through-hole design for specimen removal. Supplied sterile.

Indications for Use

Indicated for the removal of Trabecular Metal™ Osteonecrosis Intervention Implants in patients requiring implant revision or removal.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Submission Summary (Full Text)

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Zimmer TMT

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The Explant™ Osteonecrosis Intervention Implant Removal Kit Addendum to 510(k) Premarket Notification - K050766

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## Explant™ Osteonecrosis Intervention Implant Removal Kit

| Submitter Name | Zimmer Trabecular Metal Technology, Inc. |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| And Address: | 80 Commerce Drive<br>Allendale, New Jersey 07401-1600 |
| Contact Person: | Marci Halevi |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | May 4, 2005 |
| Device Trade Name: | The Explant™ Osteonecrosis Intervention Implant Removal<br>Kit |
| Device Common Name: | Explant Instruments |
| Classification Number<br>and Name: | 21CFR878.4820 General and Plastic Surgery Devices |
| Substantial<br>Equivalence: | The term "substantial equivalence" as used in this 510(k)<br>notification is limited to the definition of substantial<br>equivalence found in the Federal Food, Drug and Cosmetic<br>Act, as amended and as applied under 21 CFR 807, Subpart<br>E under which a device can be marketed without premarket-<br>approval or reclassification. A determination of substantial<br>equivalency under this notification is not intended to have<br>any bearing whatsoever on the resolution of patent-<br>infringement suits or any other patent matters. No<br>statements related to, or in support of substantial<br>equivalence herein shall be construed as an admission<br>against interest under the US Patent Laws or their<br>application by the courts. |
| Device<br>Description: | The instruments are supplied sterile in a preassembled<br>kit. Two size kits are available; a 10mm ID kit and a<br>14mm ID kit. The 10mm kit cannot be used alone and<br>must be used in combination with the 14mm kit. The<br>instrument come preassembled to Zimmer Hudson Fitting<br>Adaptors, allowing the Tubes to be driven via a Zimmer T-<br>Handle or a Zimmer Power Driver. The Hudson fittings<br>can be removed to expose a through-hole at the end of<br>the tube to allow for removal of a specimen that remains<br>in the coring tube. All components of these kits are<br>single use only. |

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| Zimmer TMT | The Explant™ Osteonecrosis Intervention Implant Removal Kit<br>Addendum to 510(k) Premarket Notification - K050766 |
|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Explant™ Osteonecrosis Intervention Implant<br>Removal Kit is intended for removal of a Trabecular<br>Metal™ Osteonecrosis Intervention Implant. |
| Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Device: | A comparison of device technological characteristics and<br>properties demonstrates that the device is substantial<br>equivalent to the cited predicate devices. |
| Conclusion: | The Explant™ Osteonecrosis Intervention Implant Removal<br>Kit is substantially equivalent to the predicate devices<br>identified in this premarket notification. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 2005

Ms. Marci Halevi Manager of Regulatory Affairs Zimmer Trabecular Metal Technology Incorporated 80 Commerce Drive Allendale, New Jersey 07401

Re: K050766

Trade/Device Name: Explant® Osteonecrosis Intervention Implant Removal Regulation Number: 21 CFR 878.4820 Regulation Name: Surgical instrument motors and accessories/attachments Regulatory Class: I Product Code: HWE Dated: March 23, 2005 Received: March 25, 2005

Dear Ms. Halevi:

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 - Ms. Marci Halevi

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,

signature

Miriam C. Provost, Ph.D. 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): K050766

Explant® Osteonecrosis Intervention Implant Removal Device Name: Kit

The Explant® Osteonecrosis Intervention Implant Indications For Use: Removal Kit is intended for removal of a Trabecular Metal™ Osteonecrosis Intervention Implant.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

E. K. Tan

mon dign-Off) Cision of General, Restorative ....... Neurological Devices

050 766