STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM

K040022 · Stryker Leibinger · HRS · Mar 12, 2004 · Orthopedic

Device Facts

• Record ID: K040022
• Device Name: STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM
• Applicant: Stryker Leibinger
• Product Code: HRS · Orthopedic
• Decision Date: Mar 12, 2004
• Decision: SESE
• Submission Type: Traditional
• 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 but are not limited to 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

The Stryker Leibinger Universal Distal Radius System is a metallic bone fixation system consisting of plates and screws used for the internal fixation of small bone fractures, specifically distal radius fractures. The system is designed for palmar, dorsal, or orthogonal application to stabilize fractures, including compression, intra-articular, and extra-articular types. It is intended for use by surgeons in an operating room setting. The device provides mechanical stabilization to the fractured bone, facilitating healing and surgical reduction. It does not involve electronic components, software, or automated processing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation system (plates and screws). Materials are consistent with standard orthopedic fixation hardware. Designed for internal fixation of small bones. Mechanical fixation principle. No energy source, software, or connectivity.

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 in patients requiring bone 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

• Rogachefsky Distal Radius Plates (K981283)
• Radius Reconstruction Plating System (K961496)
• Universal Mandible System (K014263)

Submission Summary (Full Text)

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MAR 1 2 2004

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:

Stryker® Leibinger Universal Distal Radius System

page lot

| General Information | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Stryker® Leibinger Universal Distal Radius System |
| Common Name: | Small Bone Plating System |
| Proposed Regulatory Class: | Class II |
| Device Classification: | 87HRS (21 CFR 888.3030) Single/Multiple Component Metallic Bone Fixation Appliances and Accessories<br>87LRN (21 CFR 888.3010) Bone Fixation cerclage |
| Submitter: | Stryker Leibinger<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>269-323-4226 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Wade T. Rutkoskie<br>Associate Manager RA QA<br>Phone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | January 5, 2004 |

## 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 but are not limited to compression fractures, intra-articular and extra-articular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal or orthogonal application.

## SUBSTANTIAL EQUIVALENCY INFORMATION

The Stryker® Leibinger Universal Distal Radius System is substantially equivalent to legally marketed K981283 Rogachefsky Distal Radius Plates, K961496 Radius Reconstruction Plating System, and K014263 Universal Mandible System.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

## MAR 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Wade T. Rutkoskie Associate Manager, Regulatory Affairs and Quality Assurance Stryker Instruments, Leibinger Division 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K040022

Trade/Device Name: Stryker® Leibinger Universal Distal Radius System Regulation Numbers: 21 CFR 888.3030, 21 CFR 888.3010 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories, Bone fixation cerclage Regulatory Class: II Product Codes: HRS, LR.N Dated: January 5, 2004 Received: January 7, 2004

Dear Mr. Rutkoskie:

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 - Mr. Wade T. Rutkoskie

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,

. Mark N. Mellers

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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Page 1 of 1 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Devicc Name: Stryker® Leibinger Universal Distal Radius System

Indication 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 but are not limited to compression fractures, intra-articular and extraarticular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal or orthogonal application.

Mark H. Milliman

ral. Restorative, Division of Ge and Neurological Devices

**510(k) Number** K040022

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

Or

Concurrence of CDRH, Office of device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109) X

Over-The-Counter Use

(Optional Format 1-2-96)