The PRO-TOE® Hammertoe Fixation Systems are indicated for the fixation of ostectomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Cannulated Implants in the PRO-TOE® Hammertoe Fixation Systems, with the PRO-TOE® X-FLEX, can be used with Implantable K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint),

The Implantable K-Wires are indicated for use in fixation of bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.

Device Description

The PRO-TOE® Hammertoe Fixation System is composed of implants and instruments intended for use in the fixation or reconstruction of the lesser toes. The implants within the PRO-TOE® Hammertoe System have proximal & distal fixation features and are offered in multiple sizes. The implants are manufactured from stainless steel and titanium alloy.

AI/ML Overview

This FDA 510(k) summary describes a medical device, the PRO-TOE® Hammertoe Fixation System - C2 Implant Line Addition. It is a premarket notification for a new version of an existing device, adding new sizes and updating design. As such, the submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study of its performance against acceptance criteria in the way a novel device might.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance (Implicit): The device should be structurally sound and capable of performing its intended function without new worst-case scenarios related to mechanical failure. This is inferred from the type of device (bone fixation) and the tests mentioned.	"Analysis related to pullout and static bend testing has shown that the subject implants do not present a new worst case." This indicates that the new implants perform comparably to or better than the predicate devices in terms of pullout strength and resistance to bending.
Equivalence to Predicate Devices (Implicit): The new device should perform at least as well as, and not raise new questions of safety or effectiveness compared to, the predicate device.	"The design characteristics of the subject devices 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 systems and are substantially equivalent."

Explanation: In a 510(k) submission for a device modification, the "acceptance criteria" are often implicitly tied to demonstrating equivalence to an existing legally marketed device (the predicate). The primary acceptance criterion is that the new device is "substantially equivalent" to the predicate, meaning it performs as intended and does not raise new questions of safety or effectiveness. The reported performance here directly addresses this by stating that the mechanical testing (pullout and static bend) confirms the absence of a new worst-case scenario and that the device is expected to perform "at least as well" as the predicate.

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

Sample Size for Test Set: Not explicitly stated in terms of a specific number of implants or test repetitions for the pullout and static bend testing. The analysis refers to "the subject implants" generally.
Data Provenance: The document (a 510(k) summary) does not specify the country of origin of the data. The testing described would typically be conducted in a laboratory setting, likely at the manufacturer's facility or a contracted testing lab. The study is non-clinical.

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

This information is not applicable to this type of submission. The "ground truth" for mechanical testing is based on engineered specifications and established test methods, not expert consensus on interpretations of data or images. The "experts" would be the engineers and technicians performing and interpreting the mechanical tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for situations involving human interpretation (e.g., medical imaging, clinical assessments) where there might be disagreement among reviewers. Mechanical test results are typically objective measurements.

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

No. An MRMC study is a clinical study involving multiple human readers assessing medical cases, often to compare diagnostic accuracy or treatment effectiveness. This submission for a bone fixation system modification relies on non-clinical (mechanical) testing and demonstration of substantial equivalence, not a clinical MRMC study.

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

Not applicable. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

Engineering Specifications and Standardized Test Methods: The "ground truth" for the non-clinical testing (pullout and static bend) would be defined by established engineering principles, material science, and relevant ASTM/ISO standards for mechanical testing of medical implants. The performance is compared against the known performance of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This refers to a physical medical device, not a machine learning algorithm.

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

Not applicable. This refers to a physical medical device, not a machine learning algorithm.

Summary and Key Takeaways from the Document:

This 510(k) filing for the PRO-TOE® Hammertoe Fixation System - C2 Implant Line Addition is characteristic of a submission for a device modification rather than a completely novel device or an AI/software as a medical device (SaMD). The core of the submission is to demonstrate substantial equivalence to existing predicate devices (K132895 and K140148).

Therefore, the focus is on:

Comparing the technological characteristics (materials, design, intended use).
Presenting non-clinical evidence (mechanical testing like pullout and static bend) to show that the modified device performs at least as well as the predicate and does not introduce new safety concerns ("do not present a new worst case").
Explicitly stating that no clinical evidence (human studies) was required for this demonstration of substantial equivalence.

The requested information about experts, adjudication, MRMC studies, standalone algorithm performance, and training/test set sample sizes (in the context of AI/ML) is generally not relevant to this type of device and 510(k) submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged 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

Wright Medical Technology, Incorporated Mr. Michael Mullins Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117

September 4, 2015

Re: K151838

Trade/Device Name: PRO-TOE Hammertoe Fixation System - C2 Implant Line Addition Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 30, 2015 Received: July 6, 2015

Dear Mr. Mullins:

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. Michael Mullins

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K151838

Device Name

PRO-TOE Hammertoe Fixation System - C2 Implant Line Addition

Indications for Use (Describe)

The PRO-TOE® Hammertoe Fixation Systems are indicated for the fixation of ostectomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

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

X 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)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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Headquarters Wright Medical Technology, Inc.

1023 Cherry Road Memphis, TN 38117

901 867 9971 wmt.com

Image /page/3/Picture/3 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, on the left side of the word "WRIGHT" in red font. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray font.

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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 PRO-TOE® Hammertoe Fixation System - C2 Line Addition.

1.	Submitted By:	Wright Medical Technology, Inc.
		1023 Cherry Road
		Memphis, TN 38117
	Date:	June 30, 2015
	Contact Person:	Michael Mullins
		Regulatory Affairs Specialist
		Office: (901) 867-4142
		Fax: (901) 867-4190
2.	Proprietary Name:	PRO-TOE® Hammertoe Fixation System
	Common Name:	Smooth or threaded metallic bone fixationfastener
	Classification Name - Reference:	21 CFR 888.3040- Class II
	Product Code - Device Panel:	HWC - Orthopedic
3.	Predicate Device:	K132895 - WMT Implantable K-Wire
		K140148 - PRO-TOE® HammertoeFixation System

4. Device Description

Exhibit 3 - 1

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5. Intended Use and Indications for Use

The PRO-TOE® Hammertoe Fixation Systems are 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 PRO-TOE® Hammertoe Fixation Systems, with the exception of the PRO-TOE® X-Flex, can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The Implantable K-Wires are indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.

Technological Characteristics Comparison 6.

The PRO-TOE® Hammertoe Fixation System and the legally marketed predicate devices have similar indications and dimensions and have similar geometry and identical material. The purpose of this submission is to add additional sizes of the PRO-TOE® C2 implants to the PRO-TOE® Hammertoe System as well as update design of the VO Cannulated and C2 implants.

7. Substantial Equivalence- Non-Clinical Evidence

Analysis related to pullout and static bend testing has shown that the subject implants do not present a new worst case.

8. Substantial Equivalence- Clinical Evidence N/A

Substantial Equivalence- Conclusions 9.

The design characteristics of the subject devices 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 systems and are substantially equivalent.

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.