This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System is an internal fixation device that consists of monoaxial plates and various types of screws to fit different types of fractures in the tibia and femur. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 95-415mm in length and the screws will range from 10-150mm in length.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Static strength	Substantially equivalent to predicate devices
Dynamic Fatigue Testing	Substantially equivalent to predicate devices
Shear-Off Testing	Substantially equivalent to predicate devices
Insertion Testing	Substantially equivalent to predicate devices
Pull-Out Testing	Substantially equivalent to predicate devices

Sample size used for the test set and the data provenance:

The provided text does not include information on specific sample sizes for the non-clinical tests. The tests were performed on "AxSOS 3 Ti Locking Plate System components" but the number of components tested for each criterion is not specified.

The data provenance is from non-clinical laboratory testing conducted for the AxSOS 3 Ti Locking Plate System components. The location of the laboratory or the specific country of origin for the testing data is not explicitly stated, but the sponsor is Stryker Trauma AG, Switzerland. The study type is non-clinical (benchtop) testing, not related to patient data, so "retrospective or prospective" does not apply in the typical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the study involved non-clinical mechanical testing, not a clinical evaluation requiring expert interpretation of medical images or data. Ground truth was established through standardized engineering tests.
Adjudication method for the test set:

This information is not applicable as the study involved non-clinical mechanical testing, not a clinical evaluation requiring human interpretation or adjudication.
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:

No MRMC comparative effectiveness study was done. This submission explicitly states, "Clinical testing was not required for this submission." The study focused solely on non-clinical mechanical performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No standalone (algorithm only) performance study was done. This device is a physical bone fixation system and does not involve AI algorithms.
The type of ground truth used:

The ground truth used was based on results from standardized biomechanical and mechanical tests. This includes measurements of static strength, dynamic fatigue, shear-off properties, insertion forces, and pull-out resistance, all compared against established performance benchmarks or predicate devices.
The sample size for the training set:

This information is not applicable as this submission is for a physical medical device (bone plates and screws) and does not involve an AI algorithm with a training set.
How the ground truth for the training set was established:

This information is not applicable as this submission is for a physical medical device and does not involve an AI algorithm with a training set or associated ground truth establishment.

Summary

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K123964
510(k) Summary		Page 1 of 2
Proprietary Name:	AxSOS 3 Ti Locking Plate System
Common Name:	Bone platesBone Screws		MAR 2 8 2013
Classification Name and Reference:	Single/multiple component metallic bone fixationappliances and accessories 21 CFR §888.3030
	Smooth or threaded metallic bone fixation fastener21 CFR §888.3040
Regulatory Class:	Class II
Product Codes:	87 HRS: Plate, Fixation, Bone87 HWC : Screw, Fixation, Bone
Sponsor:	Stryker Trauma AGBohnackerweg 1CH-2545 SelzachSwitzerland
Contact Person:	Estela CeliRegulatory Affairs Specialist325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6461 Fax: (201) 831-3461estela.celi@stryker.com
Date Prepared:	December 21, 2012

Description

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Intended Use

K123964

The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Page 2 of 2

Indications

The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Indications include:

Diapyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
Non-unions and malunions ●
� Normal and osteopenic bone
Osteotomies .

Summary of Technologies

Device comparison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the following predicate devices:

. K061012/K122308 AxSOS Plus Locking Plate System
K062564 Synthes LCP Distal Femur Plates .
K052390 Synthes LCP Proximal Tibia Plates .
K972323 Osteo BOS System .
K012162 Stryker Plating System Basic Fragment Set .

Non-Clinical Testing

Non-clinical laboratory testing was performed for the AxSOS 3 Ti Locking Plate System components to determine substantial equivalence. Testing demonstrated that the AxSOS 3 Ti Locking Plate System is substantially equivalent to devices currently cleared for marketing.

The following testing was performed:

. Static strength
◆ Dynamic Fatigue Testing
Shear-Off Testing .
Insertion Testing �
Pull-Out Testing

Clinical Testing

Clinical testing was not required for this submission.

Conclusion

The AxSOS 3 Ti Locking Plate System is substantially equivalent to the predicate devices identified in this premarket notification.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

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

Letter dated: March 28, 2013

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

Re: K123964 Trade/Device Name: AxSOS 3 Ti Locking Plate System 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 6, 2013 ﺒﻬﺎ. Received: March 7, 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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 -- Ms. Estela Celi

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/CDRH0ffices/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.

Mark N.Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known): __________________

Device Name: AxSOS 3 Ti Locking Plate System

Indications for Use:

The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Indications include:

Diapyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
. Non-unions and malunions
Normal and osteopenic bone .
Osteotomies .

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)

Elizabeth L.研rank -S

Division of Orthopedic Devices

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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.