WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES

K042761 · Zimmer, Inc. · KTT · Nov 17, 2004 · Orthopedic

Device Facts

• Record ID: K042761
• Device Name: WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES
• Applicant: Zimmer, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Nov 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Wristore™ Distal Radius Fracture Fixator is indicated for external fixation of the upper extremity.

Device Story

Wristore Distal Radius Fracture Fixator is a single-use external fixator for stable fracture fixation of the upper extremity. Device construct is lightweight and radiolucent; incorporates self-drilling bone pins and K-wires to secure fracture fragments. Used by clinicians in a surgical or clinical setting to provide external stabilization. Output is the physical fixation of the bone, allowing for proper healing of distal radius fractures.

Clinical Evidence

Bench testing only. Non-clinical laboratory performance testing was conducted to demonstrate the device is safe and effective.

Technological Characteristics

External fixator construct; lightweight and radiolucent materials; utilizes self-drilling bone pins and K-wires for fixation. Single-use device.

Indications for Use

Indicated for external fixation of the upper extremity in patients requiring stable fracture fixation.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Millennium Medical Technologies, Inc., Wristore Fixator (K012294)
• Immedica, Inc, TransFx Self-Drilling External Fixation Anchor Pin (K001228)

Submission Summary (Full Text)

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Traditional 510(k) Premarket Notification

| NOV 1 7 2004 | Summary of Safety and Effectiveness |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
| Contact Person: | Noah Bartsch<br>Specialist, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | 10-04-2004 |
| Trade Name: | Wristore™* Distal Radius Fracture Fixator |
| Common Name: | External Fixator |
| Classification Name: | Smooth or threaded metallic bone fixation fastener<br>Single/multiple component metallic bone fixation<br>appliances and accessories |
| Classification Reference: | 21 CFR § 888.3040, 3030 |
| Predicate Devices: | Millennium Medical Technologies, Inc., Wristore<br>Fixator, K012294, cleared March 4, 2002 |
| | Immedica, Inc, TransFx Self-Drilling External<br>Fixation Anchor Pin, K001228, cleared July 7, 2000 |
| Device Description: | The Wristore Distal Radius Fracture Fixator is a<br>single use external fixator designed to provide<br>stable fracture fixation. The lightweight,<br>radiolucent construct incorporates self-drilling bone<br>pins and K-wires to provide secure fracture fixation<br>and to capture fracture fragments. |
| Intended Use: | The Wristore Distal Radius Fracture Fixator is<br>indicated for external fixation of the upper<br>extremity. |
| Comparison to Predicate Device: | The Wristore Distal Radius Fracture Fixator has the<br>same intended use, has similar performance<br>characteristics, is manufactured from similar<br>materials using similar processes, and is similar in<br>design to the predicate devices. |
| Performance Data: | The results of non-clinical (laboratory) performance<br>testing demonstrate that the device is safe and<br>effective. |

* Trademark of Millennium Medical Technologies, Inc.

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*Trademark of Millennium Medical Technologies, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2004

Mr. Noah Bartsch Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581

Re: K042761

Trade/Device Name: Wristore™ Distal Radius Fracture Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: October 4, 2004 Received: October 5, 2004

Dear Mr. Bartsch:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for about in May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered pror to rias 2011-11-11 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 r ou may) ater see or visions 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 If your de ree 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Noah Bartsch

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with a a your e FDA finding of substantial equivalence of your device to a legally premailed predicated 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,

R. Mark H. Mellum

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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## Indications for Use

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

Device Name:

Wristore™* Distal Radius Fracture Fixator

*Trademark of Millennium Medical Technologies, Inc.

## Indications for Use:

The Wristore™* Distal Radius Fracture Fixator is indicated for external fixation of the upper extremity.

Prescription Use _X_ (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)

(Division Sign-Ot7)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K042761