VARIAX DISTAL RADIUS TORX SCREWS

K080667 · Howmedica Osteonics Corp. · HRS · Mar 19, 2008 · Orthopedic

Device Facts

• Record ID: K080667
• Device Name: VARIAX DISTAL RADIUS TORX SCREWS
• Applicant: Howmedica Osteonics Corp.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 19, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stryker® Leibinger Universal Distal Radius System is intended for use in internal fixation of the small bone fractures, primarily including distal radius fractures. Examples of these distal radius fractures include compression fractures, intra-articular and extra-articular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal, or orthogonal application.

Device Story

VariAx Distal Radius Torx Screws are metallic bone fixation components used in conjunction with Stryker Leibinger Universal Distal Radius System plates. Designed for internal fixation of distal radius fractures; used by surgeons in clinical settings. Screws provide mechanical stability to bone fragments during healing. Device is provided sterile or non-sterile. Clinical benefit includes stabilization of fractures to facilitate bone healing.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Metallic bone fixation screws; Torx drive interface; designed for use with existing plate system. Materials and dimensions consistent with predicate bone fixation hardware.

Indications for Use

Indicated for internal fixation of small bone fractures, primarily distal radius fractures, including compression, intra-articular, extra-articular, and displaced fractures requiring surgical reduction. For use in palmar, dorsal, or orthogonal applications.

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

• Stryker® Leibinger Universal Distal Radius System
• Stryker® Foot System

Submission Summary (Full Text)

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K080667

## Summary of Safety and Effectiveness VariAxTM Distal Radius Torx Screws

MAR 1 9 2008

| Proprietary Name: | VariAxTM Distal Radius Torx Screws |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone plates and screws |
| Classification Name and<br>Reference: | Single/multiple component metallic bone<br>fixation appliances and accessories, 21 CFR<br>\$888.3030 |
| Device Product Code: | 87 HRS |
| For Information Contact: | Danielle Hillman, Regulatory Affairs Associate<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | March 7, 2008 |

### Description:

The VariAx™ Distal Radius Torx Screws in combination with the plates from the Stryker® Leibinger Universal Distal Radius System are designed to treat various types of fractures of the distal radius.

## Intended Use:

The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The subject and predicate devices are available both sterile and non-sterile intended for use in fracture fixation of the distal radius. The indications for use for the VariAx™ Distal Radius Screws are provided below.

#### Indications for Use:

Stryker® Leibinger Universal Distal Radius System is intended for use in internal fixation of the small bone fractures, primarily including distal radius fractures. Examples of these distal radius fractures include compression fractures, intra-articular and extra-articular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal, or orthogonal application.

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# Substantial Equivalence:

The subject VariAx™ Distal Radius Screws share the same intended use and design concepts as that of the currently available Stryker® Leibinger Universal Distal Radius System and Stryker® Foot System. Mechanical testing demonstrated comparable mechanical properties to the predicate components and is substantially equivalent to these devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corp. % Ms. Danielle Hillman 325 Corporate Drive Mahwah, NJ 07430

MAR 1 9 2008

K080667 Re: Trade/Device Name: VariAx Distal Radius Torx Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: March 7, 2008 Received: March 10, 2008

Dear Ms. Hillman:

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. Danielle Hillman

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M Mulhearn

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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510(k) Number (if known): ≤ 000667

Device Name: VariAxTM Distal Radius Torx Screws

Indications for Use:

Stryker® Leibinger Universal Distal Radius System is intended for use in internal fixation of the small bone fractures, primarily including distal radius fractures. Examples of these distal radius fractures include compression fractures, intra-articular and extra-articular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal, or orthogonal application.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jenita
(Division Sign-Off)
for
Division of General, Restorative,
and Nom

and Neurological Devices

510(k) Number_ 60 8066