The AxSOS Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.

Device Description

This Special 510(k) submission is a line extension to address modifications made to the AxSOS Locking Plate System which was cleared in K061012. This line extension is to add tibia long plates to the existing size range of the AxSOS Locking Plate System. These monoaxial long plates will be known as AxSOS Proximal Lateral Tibia Long Plates and will be available in four length sizes in left and right configurations.

AI/ML Overview

The provided text describes a Special 510(k) submission for a line extension to the AxSOS Locking Plate System (K123403), adding "AxSOS Proximal Lateral Tibia Long Plates." This submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance (Table):

Criterion Type	Acceptance Criteria	Reported Device Performance
Risk Analysis	Compliance with ISO 14971:2007 "Medical Devices-Application of risk management to medical devices."	Risk analysis was performed according to the requirements of ISO 14971:2007. Records are retained in the design history file.
Material & Design	Substantial equivalence to predicate devices (AxSOS Proximal Lateral Tibia Plates from K061012 and SPS Proximal Lateral Tibia Plates from K050512) in terms of intended use, design, materials, and operational principles.	Finite Element Analysis (FEA) was used to identify the worst-case for plate loading. Testing was performed as per ASTM F382-99 to demonstrate equivalence. Static strength testing (axial compression) and fatigue strength testing (axial loading) were conducted. Results were used to evaluate median fatigue limits and dynamic stiffness, substantiating equivalence to the comparative proximal lateral tibia plates of the Stryker Plating System (K050512). The document states substantial equivalence to the predicate devices in intended use, design, materials, and operational principles. The tests performed are meant to support this claim for the new plates.
Mechanical (Static Strength)	To demonstrate equivalence to predicate device.	Static strength testing using axial compression was performed. Results were used to evaluate equivalence. Specific quantitative acceptance criteria or results are not provided in the summary.
Mechanical (Fatigue Strength)	To demonstrate equivalence to predicate device.	Fatigue strength testing using axial loading was conducted. Results were used to evaluate median fatigue limits and dynamic stiffness, substantiating equivalence. Specific quantitative acceptance criteria or results are not provided in the summary.

Study Information:

The document describes non-clinical testing to demonstrate substantial equivalence, rather than a clinical study evaluating the device's performance in patients in the context of typical AI/ML medical device submission.

Sample size used for the test set and the data provenance: Not applicable. This submission focuses on a mechanical device (bone plate) and uses non-clinical testing (mechanical testing, FEA) rather than clinical data from a "test set" of patients or data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and physical measurements, not expert clinical interpretation.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a bone plate, not an AI/ML diagnostic or therapeutic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
The type of ground truth used: For mechanical properties, the "ground truth" is established by adherence to recognized engineering standards (ASTM F382-99) and by comparison to the established performance of the predicate devices.
The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established: Not applicable.

Summary

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K123403

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510(k) Summary AxSOS Locking Plate System

Proprietary Name:	AxSOS Locking Plate System
Common Name:	Bone plates
Classification Name and Reference:	Single/multiple component metallic bone fixationappliances and accessories, 21 CFR §888.3030
Regulatory Class:	Class II
Product Codes:	87 HRS: Plate, Fixation, Bone
Predicate Devices:	AxSOS Locking Plate SystemStryker Plating System
For Information contact:	John DeMauro, Regulatory Affairs ConsultantStryke Trauma AGBohnackerweg 1CH-2545 SelzachSwitzerlandPhone: (201) 831-5804 Fax: (201) 831-4804john.demauro@stryker.com
Date Prepared:	November 2, 2012

Description

Intended Use

The AxSOS Locking Plate System is intended for use in long bone fracture fixation.

Indications

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Substantial Equivalence

The AxSOS Proximal Lateral Tibia Long Plates are substantially equivalent to the AxSOS Proximal Lateral Tibia Plates of the AxSOS Locking Plate System cleared under K061012 and to the Proximal Lateral Tibia Plates of the Stryker Plating System (SPS) cleared under K050512 in regards to intended use, design, materials, and operational principles as a bone fixation device.

Summary of Non-Clinical Testing and Evaluation

Risk analysis was performed according to the requirements of ISO 14971:2007 "Medical Devices-Application of risk management to medical devices." Records of the risk analysis process are retained in the design history file. Testing has been performed as per ASTM F382-99 to demonstrate equivalence of the subject device to its predicate device. Finite Element Analysis (FEA), was used to identify the worst case for plate loading. Static strength testing using axial compression was performed. Fatigue strength testing was conducted using axial loading. Results were used to evaluate median fatigue limits and dynamic stiffness, therefore substantiating equivalence to the comparative proximal lateral tibia plates of the Stryker Plating System cleared under K050512.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2013

Stryker Trauma AG % Howmedica Osteonics Corporation Ms. Estela Celi 325 Corporate Drive Mahwah, New Jersey 07430

Re: K123403

Trade/Device Name: AxSOS Proximal Lateral Tibia Long Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: March 1, 2013 Received: March 4, 2013

Dear Ms. Celi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Ms. Estela Celi

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/3/Picture/7 description: The image shows the name "Erin Keith" in a stylized font. The letters "E", "r", "i", and "n" are in a bold, sans-serif font. The letters "K", "e", "i", "t", and "h" are also in a bold font, but they are decorated with geometric shapes and lines. The overall effect is modern and eye-catching.

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use Statement

K123403 Page 1 of 1

Indications for Use

510(k) Number (if known):

Device Name: AxSOS Proximal Lateral Tibia Long Plates

Indications for Use:

Prescription Use X Over-The-Counter Use 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)

Elizabethi LErank -S

Divison of Orthopedic Devices

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.