The PRO-TOE™ VO Hammertoe Implant system is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Device Description

The subject implants are modified from the previously cleared Pro-Toe™ VO Hammertoe Implant System. They offer additional size ranges as well as additional material.

AI/ML Overview

The provided document is a 510(k) summary for the Pro-Toe™ VO Hammertoe Implant System - Line Addition. This is a premarket notification for a medical device that claims substantial equivalence to a predicate device, rather than a clinical study establishing new performance criteria. Therefore, much of the requested information, such as detailed acceptance criteria, specific device performance metrics, sample sizes for test and training sets, expert qualifications, and study designs for AI or human readers, is not applicable in this context.

Here's a breakdown of the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The primary "acceptance criteria" for a 510(k) submission like this is demonstrating substantial equivalence to a previously cleared predicate device. This is achieved through non-clinical performance testing and engineering analysis to show that the design changes (new sizes, new material) do not introduce new safety or effectiveness concerns.
Reported Device Performance: The document states: "Performance testing and engineering analysis supports the equivalence of the new sizes and shows that no new worst-case implants are introduced in this system." And, "Performance testing and engineering analysis shows that no new worst-case design is introduced in this system."
- No specific numerical performance metrics (e.g., tensile strength values, fatigue life cycles) are provided in the summary. The "performance" is described in terms of structural integrity and equivalence.

Criteria	Reported Device Performance (Summary)
Substantial Equivalence (Non-Clinical)	Performance testing and engineering analysis supports equivalence of new sizes. No new worst-case implants or designs introduced. ASTM standards address new Titanium material.

2. Sample size used for the test set and the data provenance:

N/A. This is not a clinical study involving a "test set" of patient data in the typical sense. The "test set" would refer to the implants themselves undergoing non-clinical mechanical testing, but no sample sizes or specific test details are provided.
Data Provenance: N/A, as it's not patient data. The non-clinical testing would have been conducted by the manufacturer (Wright Medical Technology, Inc.) in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This information is relevant for studies involving human interpretation or clinical data. The "ground truth" here is based on engineering principles, materials science, and mechanical testing results compared against established standards and predicate device performance.

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

N/A. Adjudication methods are used in clinical studies for reconciling differences in expert opinions. This is a mechanical/material equivalence assessment.

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:

N/A. This device is a hammertoe implant system, not a diagnostic AI system or an imaging modality requiring human reader interpretation. No MRMC study was performed.

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

N/A. This is a physical medical implant, not an algorithm.

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

For the non-clinical testing, the "ground truth" would be established engineering standards (e.g., ASTM standards referenced for Titanium) and the validated performance characteristics of the predicate device. The performance of the new implants is compared against these established benchmarks.

8. The sample size for the training set:

N/A. This device is not an AI algorithm requiring a training set. The "training data" for the engineering design would encompass material properties, biomechanical principles, and predicate device design specifications that informed the new design.

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

N/A. As above, it's not an AI training set. The "ground truth" for the design process would be based on well-established engineering principles, biomechanical data related to hammertoe correction, and the performance history of the predicate device.

Summary

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K12064S

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

APR 2 4 2012

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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™ VO Hammertoe Implant System - Line Addition.

Wright Medical Technology, Inc. (a)(1). Submitted By: 5677 Airline Road Arlington, TN 38002 February 15, 2012 Date: Ryan Bormann Contact Person: Regulatory Affairs Specialist (901) 867-4409 Pro-ToeTM VO Hammertoe Implant System -(a)(2). Proprietary Name: Line Addition Bone Plate System Common Name: Classification Name and Reference: 21 CFR 888.3040 - Class II Device Product Code, Device Panel: HWC: Orthopedic K101165 - Pro-Toe VO Hammertoe Implant (a)(3). Predicate Devices: System K022599 - Newdeal® K-Wire

(a)(4). Device Description

The subject implants are modified from the previously cleared Pro-Toe™ VO Hammertoe Implant System. They offer additional size ranges as well as additional material.

(a)(5). Intended Use

The PRO-TOE™ VO Hammertoe Implant system is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The indications statement is identical to that of the predicate Pro-Toe VO Hammertoe . Implant System's.

(a)(6). Technological Characteristics Comparison

While many of the technological characteristics are the same for the subject device system and the predicate, some design changes have been made. The subject implants are intended n to offer an extended size range in both length and diameter. In addition to extended sizes, the subject implant has also been developed to offer two different material options for each

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K120645 2/2

size. The previously cleared stainless steel is intended to be offered in all sizes as well as Titanium alloy.

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

Performance testing and engineering analysis supports the equivalence of the new sizes and shows that no new worst-case implants are introduced in this system.

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

N/A

(b)(3). Substantial Equivalence - Conclusions

The new design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. Performance testing and engineering analysis shows that no new worst-case design is introduced in this system. Additionally, ASTM standards for the new Titanium address the material change. From the evidence submitted in this 510(k) the subject device system can be expected to perform at least as well as the predicate system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms.

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

Wright Medical Technology, Inc. % Mr. Rvan Bormann 5677 Airline Road Arlington, TN 38002

APR 2 4 2012

Re: K120645

Trade/Device Name: Pro-Toe VO Hammertoe Implant System .- Line Addition Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 24, 2012 Received: March 2, 2012

Dear Mr. Bormann:

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 or any I 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. Ryan Bormann

forth in the quality systems (OS) 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,

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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Traditional 510(k) Pro-Toe™ VO Hammertoe Implant System - Line Addition

INDICATIONS FOR USE STATEMENT 5.4.

510(k) Number (if known): Not yet assigned .-K120649

Device Name: Pro-Toe™ VO Hammertoe Implant System - Line Addition

Indications for Use:

The Pro-Toe™ VQ Hammertoe Implant System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

· Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic,
Division of Surgical, Davices Division of Surges

510(k) Number

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.