The PhaLinx® Hammertoe System is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.

Device Description

The PhaLinx® Hammertoe System implants are a single piece titanium device offered in straight cannulated and 10° solid options. The implants have proximal and distal fixation features and are offered in multiple sizes.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) premarket notification for the PhaLinx Hammertoe System, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with acceptance criteria.

Specifically, the text does not include:

A table of acceptance criteria and reported device performance.
Sample size used for a test set, its data provenance, or the number/qualifications of experts for ground truth.
Adjudication method.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
Standalone algorithm performance.
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for a training set or how its ground truth was established.

The document only states that "Testing related to bending and pull-out strength were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system." and that "The safety and effectiveness of the PhaLinx® Hammertoe System is adequately supported by the mechanical testing, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification." This is a general statement about the type of testing performed, not a detailed report of study findings against specific acceptance criteria.

Summary

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

Wright Medical Technology, Inc. Mr. Val Myles Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117

November 20, 2014

Re: K142585

Trade/Device Name: PhaLinx Hammertoe System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: HWC Dated: September 12, 2014 Received: September 15, 2014

Dear Mr. Val Myles:

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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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" (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 vours.

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)

K142585

Device Name PhaLinx® Hammertoe System

The PhaLinx® Hammertoe System is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Headquarters Wright Medical Technology, Inc.

1023 Cherry Road Memphis, TN 38117

901 867 9971 vmt.com

510(K) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the WMT PhaLinx® Hammertoe System.

(a)(1). Submitted By:	Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117
Date:	November 10, 2014
Contact Person:	Val MylesRegulatory Affairs SpecialistOffice - (901) 290-5162Fax – (901) 867-4190
(a)(2). Proprietary Name:	PhaLinx® Hammertoe System
Common Name:	Smooth or threaded metallic bone fixationfastener
Classification Name and Reference:	21 CFR 888.3040 - Class II
Device Product Code, Device Panel:	HWC - Orthopedic
(a)(3). Predicate Device:	K113006: I-Fuse Hammer Toe SystemsK022599: NEWDEAL® K WIREK132895 & K140148: WMT Implantable K-Wires
(a)(4). Device Description

(a)(4). Device Description

(a)(5). INTENDED USE

The PhaLinx® Hammertoe System is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.

(a)(6). Technological Characteristics Comparison

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The PhaLinx® Hammertoe System and the legally marketed predicate devices have similar indications, dimensions and geometry, and materials. The PhaLinx® Hammertoe System is technologically substantially equivalent to the predicate devices.

(b)(1). Substantial Equivalence – Non-Clinical Evidence

Testing related to bending and pull-out strength were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system.

The safety and effectiveness of the PhaLinx® Hammertoe System is adequately supported by the mechanical testing, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification. Through the analysis of technical characteristics the new devices are substantially equivalent to the predicate devices.

(b)(2). Substantial Equivalence - Clinical Evidence

N/A

(b)(3). Substantial Equivalence - Conclusions

The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.