This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market additional plates 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 Plates (K123964). The 4.0mm System comprises the Proximal Lateral Tibia Plate, Proximal Medial Tibia Plate, Distal Medial Tibia and Distal Anterolateral Tibia Plate (K123964 & K141121). This submission adds the Proximal Lateral Humerus Plate to the 4.0mm System of the AxSOS 3 Ti Locking Plate System. The system includes three (3) types of screws available in various diameter and thread length: locking, cortical, and cancellous (K 123964 & K133440). The plates have been designed with holes that can accommodate either a locking or non-locking screw 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.

The associated accessories include:

Aiming Block, Proximal Lateral Humerus, Right ●
. Aiming Block, Proximal Lateral Humerus, Left
X-Ray Template, Proximal Lateral Humerus ●
Tag for Proximal Humerus Plate Insert ●
. Proximal Lateral Humerus Insert

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the AxSOS 3 Ti Locking Plate System. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than describing a study that proves the device meets specific acceptance criteria based on clinical outcomes or AI performance.

Therefore, many of the requested elements are not applicable to the information contained in this FDA submission.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of clinical performance or a direct comparison of the subject device's performance against such criteria. Instead, it demonstrates substantial equivalence to a predicate device through non-clinical testing.

Acceptance Criteria	Reported Device Performance
Mechanical Properties (Bending Fatigue)	Substantially equivalent to predicate device (Synthes (USA) LCP Proximal Humerus Plates, Long, K041860) as determined by biomechanical testing per ASTM F382-99.
Biocompatibility	Met requirements for Cytotoxicity, Sensitization, and Irritation tests according to FDA Blue Book Memorandum #G95-1 and ISO 10993-1.
Intended Use	Same as the predicate device: long bone fracture fixation (diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures, non-unions and malunions, normal and osteopenic bone, osteotomies).
Technological Characteristics	Similar to predicate device in design, materials (Titanium alloy Ti6Al4V-ELI), and operational principles.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set (for non-clinical testing): Not explicitly stated, but the testing would involve a sample of the manufactured plates and screws. The number is typically determined by the testing standard (e.g., ASTM F382-99 requirements).
Data Provenance: The testing was non-clinical laboratory testing. The submission is from Stryker Trauma AG, Switzerland, but the testing itself would likely be conducted in a controlled lab environment, potentially by the manufacturer or a contracted lab. The document does not specify the country of origin of the raw test data. It is prospective testing designed to support regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. This submission does not involve expert review or establishment of ground truth in the context of diagnostic performance (e.g., for an AI algorithm). The "ground truth" here is the established performance benchmarks of the predicate device and the requirements of recognized standards like ASTM F382-99 and ISO 10993.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not a study involving human reader performance or diagnostic accuracy.

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 is a medical device for fracture fixation, not an Artificial Intelligence (AI) diagnostic or assistive tool.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context refers to:

Mechanical Performance: Established mechanical properties and fatigue limits as defined by the ASTM F382-99 standard and the performance characteristics of the legally marketed predicate device (Synthes (USA) LCP Proximal Humerus Plates, Long, K041860).
Biocompatibility: Criteria outlined in FDA Blue Book Memorandum #G95-1 and the ISO 10993-1 standard.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm requiring a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of three human profiles facing to the right, stacked on top of each other.

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

December 22, 2014

Stryker Trauma AG Elijah N. Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K143138 Trade/Device Name: AxSOS 3 Ti Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS, HWC

Dated: October 31, 2014 Received: November 7, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Elijah N. Wreh

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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,

Lori A. Wiggins -S

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

Enclosure

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See PRA Statement below.

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K143138

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

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

SUBMITTER:	Stryker Trauma AGBohnackerweg 12545 SelzachSwitzerlandPhone: 201-831-5691Fax: 201-831-4691
CONTACT PERSON:	Elijah N. WrehRegulatory Affairs Specialist
Date Prepared:	December 18, 2014

DEVICE

Name of Device:	AxSOS 3 Ti Locking Plate System
Common or Usual Name:	Bone PlatesBone Screws
Classification Name:	Single/multiple component metallic bone fixation appliance and accessories 21 CFR §888.3030Smooth or threaded metallic bone fixation fastener 21 CFR §888.3040
Regulatory Class:	II
Product Codes:	HRS: Plate, Fixation, BoneHWC: Screw, Fixation, Bone
PREDICATE DEVICE:	Synthes (USA) LCP Proximal Humerus Plates, Long (K041860)No reference devices were used in this submission.

DEVICE DESCRIPTION

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screws available in various diameter and thread length: locking, cortical, and cancellous (K 123964 & K133440). The plates have been designed with holes that can accommodate either a locking or non-locking screw 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.

The associated accessories include:

Aiming Block, Proximal Lateral Humerus, Right ●
. Aiming Block, Proximal Lateral Humerus, Left
X-Ray Template, Proximal Lateral Humerus ●
Tag for Proximal Humerus Plate Insert ●
. Proximal Lateral Humerus Insert

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 ●

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The device comparison showed that the subject device is substantially equivalent in intended use, design and operational principles to the previously cleared Synthes (USA) LCP Proximal Humerus Plates, Long (K041860). The subject plates are substantially equivalent to the predicate device in regards to intended use, design, materials, and operational principles for use for long bone fracture fixation.

PERFORMANCE DATA

Non-Clinical Test

Non-clinical laboratory testing was performed on the worst case subject plates to determine substantial equivalence. The following testing was performed:

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"Standard Specification and Test Method for Metallic Bone Plates" as per ASTM F382-99 (reapproved 2008)
Biomechanical testing was conducted to evaluate the bending fatigue properties as per ASTM F382-99 (reapproved 2008) to compare the mechanical properties of the subject plates to the previously cleared Synthes (USA) LCP Proximal Humerus Plate, long (K041860). A fracture gap model was used to set up the plates for the determination of fatigue properties.

Testing demonstrated that the subject plates are substantially equivalent to the marketed predicate device.

Biocompatibility Testing

The biocompatibility evaluation for the subject AxSOS 3 Ti Locking Plate System was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, "" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

· Cytotoxicity
· Sensitization
· Irritation

The plates are categorized as per EN ISO 10993-1:2009 (E) as "Implant Device" with "Tissue/bone" contact duration > 30 days. The material is Titanium allov (Ti6A14V-ELI) as per ASTM F136.

All Class II instruments are categorized as per EN ISO 10993-1: 2009 (E) as an "Implant Device" with "Tissue/bone" contact of duration <24 hours.

Animal Study

Animal testing was not required for this submission.

Clinical Testing

Clinical testing was not required for this submission.

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CONCLUSIONS

The subject device has the same intended use and similar technological characteristics as the predicate device. The non-clinical laboratory data support the safety of the subject AxSOS 3 Ti Locking Plate System and demonstrate that the subject device should perform as intended in the specified use conditions. Therefore, the subject AxSOS 3 Ti Locking Plate System is substantially equivalent to the predicate device identified throughout this submission.

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.