PRO-TOE HAMMERTOE FIXATION SYSTEM

K140148 · Wrightmedicaltechnologyinc · HWC · Mar 7, 2014 · Orthopedic

Device Facts

• Record ID: K140148
• Device Name: PRO-TOE HAMMERTOE FIXATION SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HWC · Orthopedic
• Decision Date: Mar 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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.

Device Story

PRO-TOE® Hammertoe Fixation System consists of metallic implants (stainless steel or titanium) and instruments for lesser toe reconstruction; includes cannulated implants and implantable K-wires. Used by orthopedic surgeons in clinical settings for fixation of osteotomies and stabilization of joints. Cannulated implants facilitate K-wire delivery; K-wires serve as guide pins or temporary stabilization for outlying joints like MTP. System provides mechanical fixation to maintain bone alignment during healing; benefits patients by correcting toe deformities and stabilizing joints post-procedure.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing (mathematical mechanical analysis of static bend testing).

Technological Characteristics

Materials: surgical grade stainless steel or titanium. Components: cannulated and non-cannulated metallic bone fixation fasteners and K-wires. Design: proximal and distal fixation features, multiple sizes. Energy source: none (mechanical). Sterilization: not specified.

Indications for Use

Indicated for patients requiring fixation of osteotomies and reconstruction of lesser toes (hammertoe, claw toe, mallet toe) and metatarsophalangeal joint instability. Cannulated implants and K-wires used for bone fracture fixation, bone reconstruction, and temporary stabilization of outlying joints (e.g., MTP joint).

Regulatory Classification

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.

Predicate Devices

• PRO-TOE™ VO Hammertoe Implant System (K101165)
• PRO-TOE™ Hammertoe Implant System (K120645)
• Trilliant Hammer Toe Implant (K122959)
• WMT Implantable K-Wires (K132895)

Submission Summary (Full Text)

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PRO-TOE® Hammertoe System

Traditional 510(k)

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Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 www.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 use of the WMT PRO-TOE® Hammertoe Fixation System line additions.

(a)(1). Submitted By:

Date:

Contact Person:

(a)(2). Proprietary Name:

Common Name:

Classification Name and Reference:

Device Product Code, Device Panel:

(a)(3). Predicate Device:

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002

January 21, 2014

Val Myles Regulatory Affairs Specialist I Office - [phone] Fax - [phone]

PRO-TOE® Hammertoe Fixation System

Smooth or threaded metallic bone fixation fastener

21 CFR 888.3040 - Class II

HWC- Orthopedic

K101165 – PRO-TOE™ VO Hammertoe Implant System

K120645 - PRO-TOE™ Hammertoe Implant System

K122959 - Trilliant Hammer Toe Implant

K132895 - WMT Implantable K-Wires

## (a)(4). Device Description

The PRO-TOE® Hammetoe Fixation System is composed of implants and instruments intended for use in the fixation or reconstruction of the lesser toes. The implants within the

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PRO-TOE® Hammertoe System have proximal & distal fixation features and will be offered in multiple sizes. The implants are manufactured from stainless steel or titanium.

This submission seeks to add previously cleared WMT Implantable K-Wires to the system for use with cannulated implants, for which clearance is also sought in this submission. The WMT Implantable 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.

## (a)(5). INTENDED 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 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.

## (a)(6). Technological Characteristics Comparison

The PRO-TOE® Hammertoe Fixation System and the legally marketed predicate devices have similar indications, dimensions and geometry, and are identical in material. The purpose of this submission is to add PRO-TOE® VO Cannulated and PRO-TOE® C2 implants to the PRO-TOE® Hammertoe System. Indications have been updated to include the additional indication for temporary stabilization of outlying joints (e.g. MTP joint), identical to that of the previously cleared WMT Implantable K-Wire.

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

Mathematical mechanical analysis related to static bend testing has shown that the subject implants do not present a new worst case.

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

N/A

## (b)(3). Substantial Equivalence - Conclusions

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.

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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 stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Public Health Service

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

March 7, 2014

Wright Medical Technology, Inc. Ms. Val Myles Regulatory Affairs Specialist I 5677 Airline Road Arlington, Tennessee 38002

Re: K140148

Trade/Device Name: PRO-TOE® Hammertoe Fixation 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 9, 2014 Received: January 22, 2014

Dear Ms. 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 that I Dr has interes and regulations administered by other Federal agencies. You must or any I odotal 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 - Ms. Val Myles

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Vincent 脚

for

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

Enclosure

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#### PRO-TOE® Hammertoe System

### Traditional 510(k)

## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K140148

Device Name

PRO-TOE® Hammertoe Fixation System

### Indications for Use (Describe)

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

Cannulated Implants in the PRO-TOE® Hammerton Fixation Systems can be used with K-wires for the delivery of implants of the temporary stabilization of outlying joints (c.g. MTP Joint).

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

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)

# Elizabeth L际rank -S

Division of Orthopedic Devices

FORM FDA 3881 (1/14)

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