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 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, 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.

AI/ML Overview

This document describes a 510(k) submission for the Stryker Leibinger Resorbable Fixation System. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It is not a clinical study designed to test acceptance criteria based on performance endpoints. Therefore, most of the requested information is not applicable to this type of regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The primary acceptance criterion for a 510(k) submission is showing substantial equivalence to existing predicate devices. This is demonstrated by comparing material, design, operational principle, and intended use. Specific quantitative performance acceptance criteria are typically not defined in such a summary, as the focus is on a comparative assessment rather than absolute performance targets.
Reported Device Performance: The summary states that "Mechanical testing has shown that the Stryker Leibinger device is equivalent in strength to the Walter Lorenz LactoSorb device." This is the key performance claim made.

Acceptance Criteria (for 510(k))	Reported Device Performance
Substantial Equivalence to Predicate Devices (Howmedica Leibinger Resorbable Fixation System, LactoSorb Trauma Plating System, Macropore Protective Sheet, BiosorbFX 1.5/2.0 Bioabsorbable Fixation System) in material, design, operational principle, and intended use.	The Stryker Leibinger device is found to be substantially equivalent to the aforementioned predicate devices.
Mechanical strength equivalent to a predicate device.	Mechanical testing showed the Stryker Leibinger device is equivalent in strength to the Walter Lorenz LactoSorb device.

2. Sample Size Used for the Test Set and Data Provenance
This is a 510(k) submission, not a stand-alone clinical study. The "test set" in this context would refer to data used for mechanical testing for equivalence.

Sample Size: Not specified. Mechanical testing typically involves a sufficient number of samples to demonstrate statistical equivalence, but the exact number is not disclosed in this summary.
Data Provenance: Not specified, but generally, such testing is performed in-house by the manufacturer or by a contracted laboratory. It is implied to be laboratory testing rather than human subject data. The data is retrospective in the sense that it was performed on manufactured devices for comparison.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth as typically understood in clinical or AI studies (e.g., expert consensus on medical images) is not relevant for this type of mechanical equivalence testing. The "ground truth" here is the established mechanical properties of the predicate device.

4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of clinical outcomes or diagnostic interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a medical device submission for a physical implantable system, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or software device. "Standalone performance" in this context could refer to the mechanical performance of the device itself, which was established as equivalent to a predicate device through mechanical testing.

7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" was likely the established mechanical properties (e.g., strength, stiffness) of the Walter Lorenz LactoSorb device, a legally marketed predicate device. This would be based on its specifications, published data, or direct testing of the predicate.

8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning study, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.

Summary

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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 BoneFixation Appliances and Accessories
Classification Code:	87HRS
Submitter:	Stryker Leibinger4100 E. Milham Ave.Kalamazoo, MI 49001
Submitter's RegistrationNumber:	1811755
Manufacturer's RegistrationNumber:	1811755
Contact Person:	Kristyn R. KelleyProject EngineerQuality Assurance and Regulatory Affairs616-323-7700 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

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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

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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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

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

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.