The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Indications include:
• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• Non-unions and malunions
• Normal and osteopenic bone
• Osteotomies
• Periprosthetic fractures of the femur and proximal tibia

Device Description

This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market additional plates and screws within the AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System includes anatomically contoured monoaxial locking plates. The 5.0mm System consists of the Distal Lateral Femur Plate (K123964). The 4.0mm System comprises the Proximal Lateral Tibia Plate (K123964) as well as the subject devices being the Distal Anterolateral Tibia Plate, the Distal Medial Tibia Plate and the Proximal Medial Tibia Plate. The system includes four (4) types of screws available in various diameter and thread length: locking, cortical, cancellous (K123964 & K133440) as well as the subject periprosthetic screws. The plates have been designed with holes that can accommodate either a locking or non-locking screw both at the peri-articular end and along the shaft of the plates also have an oblong hole located at the metaphyseal junction used to aid in positioning. The subject components will be available sterile and non-sterile.

AI/ML Overview

The provided text describes a medical device, the "AxSOS 3 Ti Locking Plate System," and its clearance process through a 510(k) submission to the FDA. This submission focuses on establishing substantial equivalence to previously marketed predicate devices rather than demonstrating novel performance against defined acceptance criteria through a clinical or standalone study.

Therefore, many of the requested categories regarding acceptance criteria, study details, and expert involvement are not applicable to the information provided.

Here's a breakdown of the relevant and non-applicable information based on the input:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Not explicitly stated as such for performance)	Reported Device Performance (Non-Clinical Testing)
Mechanical properties as per ASTM F382-99 (reapproved 2008)	Demonstrated substantial equivalence to currently marketed predicate devices (Synthes LCP Distal Tibia Plates, Synthes 3.5/4.5MM LCP Medial Proximal Tibia Plates, Peri-Loc Bone Plating and Screw System).
Mechanical properties as per ASTM F543-07	Demonstrated substantial equivalence to currently marketed predicate devices (Synthes Peri-Prosthetic Screws).
Intended Use	Substantially equivalent to predicate devices for long bone fracture fixation.
Design, Materials, and Operational Principles	Substantially equivalent to predicate devices.

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

Not Applicable. No test set of patient data (e.g., images for an AI device) was used. The "test set" in this context refers to the worst-case subject plates and screws used for non-clinical, mechanical testing. The provenance of these physical samples is not specified, but they would be manufactured by the sponsor (Stryker Trauma AG).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. As no patient data test set was used, no experts were involved in establishing ground truth for such data. Mechanical testing relies on standardized test methods (ASTM) and engineering evaluations rather than expert consensus on medical conditions.

4. Adjudication method for the test set:

Not Applicable. No patient data test set requiring adjudication was used.

5. 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 device is a bone plate and screw system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and related metrics are irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

For the non-clinical testing, the "ground truth" was derived from established mechanical standards and specifications (ASTM F382-99 and ASTM F543-07) and comparison to the performance of predicate devices. There is no biological "ground truth" in the clinical sense for this type of submission.

8. The sample size for the training set:

Not Applicable. No training set, in the context of machine learning or AI, was used for this type of medical device submission.

9. How the ground truth for the training set was established:

Not Applicable. As no training set was used, no ground truth needed to be established for it.

Summary

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510(k) Summary

Proprietary Name:	AxSOS 3 Ti Locking Plate System	JUN 20 2014
Common Name:	Bone PlatesBone Screws
Classification Name and Reference:	Single/multiple component metallic bone fixation appliance and accessories 21 CFR §888.3030
	Smooth or threaded metallic bone fixation fastener21 CFR §888.3040
Regulatory Class:	Class II
Product Codes:	HRS: Plate, Fixation, BoneHWC: Screw, Fixation, Bone
Sponsor:	Stryker Trauma AG
Contact Person:	Elijah N. WrehRegulatory Affairs Specialist325 Corporate DriveMahwah, NJ 07430elijah.wreh@stryker.comPhone: 201-831-5691Fax: 201-831-4691

Description

Date Prepared:

April 29, 2014

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oblong hole located at the metaphyseal junction used to aid in positioning. The subject

components will be available sterile and non-sterile.

Intended Use

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

Indications for Use

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

Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
. Non-unions and malunions
Normal and osteopenic bone .
. Osteotomies
Periprosthetic fractures of the femur and proximal tibia .

Summary of Technology

The device comparison showed that the subject device is substantially equivalent in intended use,

design, materials and operational principles to the following predicate devices:

. Synthes LCP Distal Tibia Plates (K013248)
Synthes (USA) 3.5/4.5MM LCP Medial Proximal Tibia Plates (K050646) .
Peri-Loc Bone Plating and Screw System (K083032) .
. Synthes Peri-Prosthetic Screws (K041533)

The subject plates and screws are substantially equivalent to the predicate devices in regards to

intended use, design, materials, and operational principles for long bone fracture fixation.

Non-Clinical Test

Non-clinical laboratory testing was performed on the worst case subject plates to determine

substantial equivalence. The following testing was performed:

"Standard Specification and Test Method for Metallic Bone Plates" as per ASTM F382-. 99 (reapproved 2008)
"Standard Specification and Test Methods for Metallic Medical Bone Screws as per . ASTM F 543-07"

Testing demonstrated that the subject plates are substantially equivalent to the currently

marketed predicate devices.

Clinical Testing

Clinical testing was not required for this submission.

Conclusion

The subject AxSOS 3 Ti Locking Plate System is substantially equivalent to the predicate

devices identified throughout this submission.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with three overlapping wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Stryker Trauma AG Mr. Elijah Wreh Regulatory Affair Specialist 325 Corporate Drive Mahwah. New Jersey 07430

Re: K141121

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. HWC Dated: April 29, 2014 Received: May 01, 2014

June 20, 2014

Dear Mr. Wreh:

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 - Mr. Elijah Wreh

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 -A

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use	Form Approved: OMB No. 0910-0120
	Expiration Date: January 31, 2017
	See PRA Statement below.
510(k) Number ( if known )	K141121
Device Name	AxSOS 3 Ti Locking Plate System
Indications for Use ( Describe )	The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation.
Indications include:
	• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
	• Non-unions and malunions
	• Normal and osteopenic bone
	• Osteotomies
	• Periprosthetic fractures of the femur and proximal tibia
Type of Use ( Select one or both, as applicable )
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Elizabeth L. Frank -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.