The PHALINX® Hammertoe System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Cannulated Implants in the PHALINX® Hammertoe Fixation System can be used with k-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

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. This submission seeks to add PHALINX® K-Wires to the system for use with cannulated implants. The PHALINX® K-wires are offered in surgical grade stainless steel. A range of diameters and lengths are offered from the manufacturer and planning should be conducted prior to implantation to determine the best fit.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "PHALINX® Hammertoe System." It describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria as would be expected for an AI/software as a medical device (SaMD).

This document is for a physical orthopedic implant system, not a software or AI device. Therefore, the requested information categories regarding acceptance criteria, performance studies, sample sizes, ground truth, experts, and MRMC studies, which are typical for SaMD, are not applicable here.

The document primarily focuses on establishing "substantial equivalence" to predicate physical devices, meaning it is similar enough in design, materials, and intended use that it does not raise new questions of safety or effectiveness.

Here's a breakdown of what is available in the document, framed against your request, to highlight the absence of SaMD-specific information:

A table of acceptance criteria and the reported device performance:
- Not applicable / Not present. This submission does not provide acceptance criteria for a performance study as might be done for SaMD. Instead, it relies on substantial equivalence.
- The document states: "Testing related to bending and pull-out strength was previously provided in the predicate device filings. Therefore, no testing was provided for the subject device as the design is identical." This implies that the current device is considered to meet the same performance characteristics as its predicates based on its identical design.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not present. There is no "test set" in the context of an AI/software evaluation.
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):
- Not applicable / Not present. "Ground truth" in the context of an AI/software evaluation is not relevant for this physical device submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not present.
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 / Not present. MRMC studies are specific to evaluating AI in diagnostic contexts.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not present. This is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not present.
The sample size for the training set:
- Not applicable / Not present. No "training set" for an algorithm.
How the ground truth for the training set was established:
- Not applicable / Not present.

Summary of Device and its Basis for Clearance:

Device Name: PHALINX® Hammertoe System
Intended Use: Fixation of osteotomies and reconstruction of lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants can be used with K-wires for delivery or temporary stabilization of outlying joints.
Device Description: Single-piece titanium device (straight cannulated and 10° solid options) with proximal and distal fixation features, offered in multiple sizes. This submission specifically adds PHALINX® K-Wires (surgical grade stainless steel) for use with cannulated implants.
Basis for Clearance (Substantial Equivalence): The device design is stated to be "identical to the currently marketed PHALINX® Hammertoe System." Therefore, new performance testing (like bending and pull-out strength) was not provided, as it was previously submitted for the predicate device.
Clinical Evidence: "N/A" (Not Applicable)
Conclusion: The design characteristics "do not raise any new types of questions of safety or effectiveness." The device is expected to perform "at least as well as the predicate device."

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, Incorporated Mr. Val Myles Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117

April 29, 2015

Re: K150252

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: January 29, 2015 Received: February 3, 2015

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 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)

K150252

Device Name PHALINX® Hammertoe System

Indications for Use (Describe)

The PHALINX® Hammertoe System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Cannulated Implants in the PHALINX® Hammertoe Fixation System can be used with k-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

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)

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Headquarters Wright Medical Technology, Inc.

1023 Cherry Road Memphis, TN 38117

901 867 9971 wmt.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 WMT PHALINX® Hammertoe System.

(a)(1). Submitted By:	Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117
Date:	January 29, 2015
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:	K142585: PHALINX® Hammertoe SystemK140148: PRO-TOE® Hammertoe FixationSystemK132895: WMT Implantable K-Wires

(a)(4). Device Description

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(a)(5). INTENDED USE

The PHALINX® Hammertoe System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Cannulated Implants in the PHALINX® Hammertoe System can be used with k-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

(a)(6). Technological Characteristics Comparison

The subject PHALINX® Hammertoe System design is identical to the currently marketed PHALINX® Hammertoe System.

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

Testing related to bending and pull-out strength was previously provided in the predicate device filings. Therefore, no testing was provided for the subject device as the design is identical.

(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.