The AxSOS Locked Plating System in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The AxSOS Locked Plating System is indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia, and the distal femur.

Device Description

This Special 510(k) submission is intended to address modifications to the Device Description. This Special 510(k) backing Insert is being modified as part of a line extension of the AxSOS® Locked Plating System. The AxSOS® Locked Plating System contains 4mm Locking Inserts to which changes are being made to improve manufacturability. The locking inserts are made from stainless steel per ASTM F138 and ASTM F139. The AxSOS® Locked Plating 4.0mm Locking Inserts have similar or identical and material properties to the predicate 4.0mm Locking Inserts determined substantially equivalent via 510(k) K050512.

AI/ML Overview

This document describes a Special 510(k) submission for a line extension of 4mm locking inserts for the AxSOS® Locked Plating System. This type of submission is for modifications to a legally marketed device that do not alter its intended use or fundamental scientific technology. Therefore, the "study" conducted is primarily non-clinical mechanical testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Reported Device Performance
Mechanical/Functional	Insertion Force	Met performance requirements; as safe and effective as predicates.
	Screw Insertion	Met performance requirements; as safe and effective as predicates.
	Push Out	Met performance requirements; as safe and effective as predicates.
	Torsion	Met performance requirements; as safe and effective as predicates.
	Bending	Met performance requirements; as safe and effective as predicates.
	Fatigue	Met performance requirements; as safe and effective as predicates.
Material Properties	(Not explicitly listed as a test, but stated)	Similar or identical to predicate 4.0mm Locking Inserts (ASTM F138/F139).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for each test. The text mentions "non-clinical laboratory testing was performed," implying a sufficient number of samples were tested to generate reliable data for each mechanical test.
Data Provenance: Not explicitly stated, but assumed to be laboratory-generated per standard non-clinical testing protocols for medical devices. There is no indication of country of origin for the data, but the manufacturer is based in New Jersey, USA. The testing is retrospective in the sense that it's performed on manufactured devices to compare them to an existing predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. This is a non-clinical, mechanical testing study for substantial equivalence, not a clinical study involving human patient data and expert interpretation. The "ground truth" is defined by established engineering and material science standards and the performance of the predicate device.

4. Adjudication Method for the Test Set

Not Applicable. As this is non-clinical mechanical testing, there is no need for an adjudication method in the context of expert consensus or dispute resolution. Test results are objective measurements against defined performance requirements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC study was not done. The submission explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This is a purely non-clinical submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is a physical medical device (bone plating system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on established engineering performance requirements and material standards (e.g., ASTM F138 and ASTM F139 for stainless steel), and the demonstrated performance of the legally marketed predicate device (K050512). The goal is to show the modified device performs "as safe and effective as their predicates."

8. The Sample Size for the Training Set

Not Applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. It is a physical product undergoing mechanical validation.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set, this question is not relevant.

Summary

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K110176 * 1/d

AxSOSE Locked Plating System I.Ine Extension of 4mm Locklug Inserts

Special 510(k)

FEB 15 201

510(k) Summary of Safety and Effectivencss:

AxSOS® Locked Plating System Line Extension of 4mm Locking Inserts

Sponsor

Howmedica Osteonics Corp. 325 Corporate Drive Mahwalı, NJ 07430

Contact Person

Anthony Dennis Specialist, Regulatory Affairs Howmedica Osteonics Corp. 325 Corporate Drive Mahwalı, NJ 07430 Phone: (201) 831-5804

Date Prepared:	January 19, 2011
Proprietary Name:	AxSOS® Locked Plating System Line Extension of 4mm LockingInserts
Common Name:	Bone plates and screws
Classification Name:	21 CFR §888.3030Single/multiple component metallic bone fixation appliances andaccessories
Classification Name:	21 CFR §888.3040Smooth or Threaded metallic bone fixation fastener

Legally Marketed Device to Which Substantial Equivalence is Claimed:

Howmedica Osteonics Stryker Locked Plating System: K050512

Device Description: This Special 510(k) submission is intended to address modifications to the Device Desertifican. This Openal 910(x) backing Insert is heing modified as part of a line

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K110176 #2/d

AxSOS Locked Plating System Line Extension of 4mm Locking Inserts

Special 510(k)

extension of the AxSOS® Locked Plating System. The AxSOS® Locked Plating System contains 4mm Locking Inserts to which changes are being made to improve manufacturability. The locking inserts are made from stainless steel per ASTM F138 and ASTM F139. The AxSOS® Locked Plating 4.0mm Locking Inserts have similar or identical and material properties to the predicate 4.0mm Locking Inserts determined substantially equivalent via 510(k) K050512.

Intended Use: The AxSOS® Locked Plating System Line Extension of 4mm Locking Insert modifications do not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject plates are provided below.

Indications:

The AxSOS Locked Plating System in the Stryker Locked Plating System is intended for use in long bone fracture fixation. The AxSOS Locked Plating System is indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia, and the distal femur.

Summary of Technologies: The technological characteristics (material, design, sizes, and operational principles) of the AxSOS® Locked Plating 4.0mm Locking Inserts are similar or identical to the predicate device, K050512.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The following mechanical/functional testing was performed: insertion force, screw insertion, push out, torsion, bending, and fatigue. The testing demonstrated that the AxSOS® Locked Plating 4.0mm Locking Inserts met performance requirements and are as safe and effective as their predicates.

Clinical Testing: None provided as a basis for substantial equivalence

Conclusion:

The AxSOS® Locked Plating 4.0mm Locking Inserts is substantially equivalent to the predicate devices identified in this pre-market notification.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines extending from its body.

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

Howmedica Osteonics Corp. % Mr. Anthony Dennis 325 Corporate Drive Mahwah, New Jersey 07430

FEB 15 201

Re: K110176

Trade/Device Name: AxSOS® Locked Plating System Line Extension of 4mm Locking Inserts 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: January 20, 2011 Received: January 21, 2011

Dear Mr. Dennis:

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.

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Page 2 - Mr. Anthony Dennis

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 of medical 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

A.S. B. Rh
for

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

Enclosure

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Indications for Use

510(k) Number (if known): K | | Ol 76

Device Name: AxSOS® Locked Plating System Line Extension of 4mm Locking Inserts

Indications For Use:

The AxSOS Locked Plating System in the Stryker Locked Plaing System are intended for use in I The AxSOS Econod Plating Official in the Stystem is indicated for firstion of long long oone fracture fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia, and the distal femur.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(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)

Page 1 of 1

for M. Melkerson

(Division Sign-Off) Division of Surgical Orthopedic, and Restorative Devices

510(k) Number K110776

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.