STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM

K993061 · Stryker Instruments · MAI · Nov 19, 1999 · Orthopedic

Device Facts

• Record ID: K993061
• Device Name: STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM
• Applicant: Stryker Instruments
• Product Code: MAI · Orthopedic
• Decision Date: Nov 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Stryker Leibinger Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.

Device Story

Resorbable fixation system for craniofacial/midfacial bone trauma or reconstruction; includes plates (straight, curved, X, Y, zigzag, L, box, ladder, panel) and mesh; screws available in 1.7mm, 2.0mm, and 2.2mm diameters. Plates/mesh are intraoperatively contoured via heating. Used by surgeons in clinical settings. Provides mechanical stabilization of bone segments during healing. Benefits include resorbable material eliminating need for secondary removal surgery.

Clinical Evidence

Bench testing only; no clinical data presented. Mechanical testing confirmed strength equivalence to predicate devices.

Technological Characteristics

Fabricated from polylactide and polyglycolide terpolymer. Plates (1.0mm thickness) and mesh (0.7mm thickness) are heat-contoured intraoperatively. Screws available in 1.7mm, 2.0mm, and 2.2mm diameters. Non-metallic, resorbable fixation system.

Indications for Use

Indicated for fixation of craniofacial and midfacial skeletal bones following trauma or for reconstruction in adult and pediatric patients. Contraindicated for use in the mandible and full load-bearing procedures.

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

• Howmedica Leibinger Resorbable Fixation System (K982531)
• LactoSorb Trauma Plating System (K971870)
• Macropore Protective Sheet (Protego System) (K972913)
• BiosorbFX 1.5/2.0 Bioabsorbable Fixation System (K982139)

Submission Summary (Full Text)

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# Nov 1 9 1999

## 510(k) Summary of Safety and Effectiveness: Stryker Leibinger Resorbable Fixation System

## General Information

| Proprietary Name: | Stryker Leibinger Resorbable Fixation System |
|----------------------------------------|---------------------------------------------------------------------------------------------------------|
| Common Name: | Small Bone Plating System |
| Classification Name: | Single/Multiple Component Metallic Bone<br>Fixation Appliances and Accessories |
| Classification Code: | 87HRS |
| Submitter: | Stryker Leibinger<br>4100 E. Milham Ave.<br>Kalamazoo, MI 49001 |
| Submitter's Registration<br>Number: | 1811755 |
| Manufacturer's Registration<br>Number: | 1811755 |
| Contact Person: | Kristyn R. Kelley<br>Project Engineer<br>Quality Assurance and Regulatory Affairs<br>616-323-7700 x3814 |
| Summary Preparation Date: | September 7, 1999 |

## Equivalent Devices

The Stryker Leibinger Resorbable Fixation System is equivalent to the Howmedica Leibinger Resorbable Fixation System, Howmedica, K982531; the LactoSorb Trauma Plating System, Walter Lorenz, subsidiary of Biomet, K971870; the Macropore Protective Sheet (Protego System), Pacific Materials and Interfaces, K972913; and the BiosorbFX 1.5/2.0 Bioabsorbable Fixation System, Bionx Implants, Inc., K982139.

## Device Description

The Stryker Leibinger Resorbable Fixation System is a modification of the Howmedica Leibinger Resorbable Fixation System, K982531. This second generation of products includes plates and screws in various configurations. Plates include but are not limited to straight, curved, "X", "Y", zigzag, "L", box,

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ladder, and panel designs in varying lengths which are attached to the bone using screw fixation. The plates have a thickness of 1.0mm. The system also contains a mesh which is available in a thickness of 0.7mm. Screws are available in 1.7 mm, 2.0 mm and 2.2 mm diameters and standard craniofacial lengths. The plates and mesh can be intraoperatively contoured by heating. The subject device is fabricated from a polylactide and polyglycolide terpolymer. Mechanical testing has shown that the Stryker Leibinger device is equivalent in strength to the Walter Lorenz LactoSorb device.

## Intended Use

The Stryker Leibinger Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.

## Substantial Equivalence

The subject device is substantially equivalent to the above mentioned devices in material, design, operational principle and intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 19 1999

Ms. Kristyn R. Kelley Project Engineer Quality Assurance and Regulatory Affairs Stryker Leibinger 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K993061 Stryker Leibinger Resorbable Fixation System Regulatory Class: II Product Codes: MAI, HWC, and HRS Dated: September 7, 1999 September 13, 1999 Received:

Dear Ms. Kelley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Ms. Kristyn R. Kelley

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your blown) privalence of your device to a legally rinding of cabboanderice results in a classification for your marketed produce awits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of vitto draghosere actross// productionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be information on your with of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James F. Dillard III

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Stryker Leibinger Resorbable Fixation System

Indications For Use:

The Stryker Leibinger Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--------------------------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K993061 |
| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The- Counter Use |
| (Optional Format 1-2-96) | |