ToeTac™ 10° Hammertoe Fixation System

K161778 · Restore Surgical, LLC Dba Instratek · HWC · Nov 22, 2016 · Orthopedic

Device Facts

• Record ID: K161778
• Device Name: ToeTac™ 10° Hammertoe Fixation System
• Applicant: Restore Surgical, LLC Dba Instratek
• Product Code: HWC · Orthopedic
• Decision Date: Nov 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ToeTac™ Hammertoe Fixation System indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Device Story

ToeTac™ 10° Hammertoe Fixation System is a bone fixation device used in orthopedic surgery. It consists of a threaded PEEK implant and associated surgical instruments for site preparation and delivery. The system is provided in a sterile kit. It is used by surgeons in clinical settings to stabilize bone during the reconstruction of lesser toes (hammertoe, claw toe, mallet toe). The implant provides mechanical fixation to support bone healing following osteotomy or corrective procedures.

Clinical Evidence

Bench testing only. Performance testing included pull-out, torque, and static and dynamic bend strength testing.

Technological Characteristics

Threaded PEEK (polyetheretherketone) implant. Includes bone preparation instrumentation and driver. Sterile packaged kit. Mechanical fixation principle.

Indications for Use

Indicated for fixation of osteotomies and reconstruction of lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

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

• ToeTac™ Hammertoe Fixation System (K150443)
• Kirschner Wire (K112254)

Submission Summary (Full Text)

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures in profile facing right.

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

Restore Surgical LLC Dba Instratek Jeff Seavey President 15200 Middlebrook Dr., Suite G Houston, Texas 77058

November 22, 2016

Re: K161778

Trade/Device Name: ToeTac™ 10° 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: November 17, 2016 Received: November 18, 2016

Dear Mr. Seavey:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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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 [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" (21 CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# 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) K161778

Device Name ToeTac™ 10° Fixation System

Indications for Use (Describe)

The ToeTac™ 10° Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for the 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)

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## SECTION 007: 510(K) SUMMARY

| Submission Correspondent<br>and Owner: | Restore Surgical LLC, dba Instratek<br>15200 Middlebrook Dr., Suite G<br>Houston, TX 77058<br>USA<br><br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Contact: Mr. Jeff Seavey<br>President |
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| Date summary prepared: | June 28, 2016 |
| Device trade name: | ToeTac™ 10° Hammertoe Fixation System |
| Device classification name: | Bone Screw, Fixation, fastener |
| Classification: | Class II |
| Product Code: | HWC |
| Regulation/Description: | 880.3040, Smooth or threaded metallic bone fixation |
| Predicate Devices | ToeTac™ Hammertoe Fixation System, K150443<br>Kirschner Wire, K112254 |
| Description of the device: | The Instratek ToeTac™ 10° Hammertoe Fixation System includes a<br>threaded PEEK implant for bone fixation and a set of instruments<br>used for implant site preparation and delivery. The device is offered<br>in a sterile packaged kit that contains the implant, bone preparation<br>instrumentation and a driver, as well as a single packaged implant. |
| Intended use of the device: | The ToeTac™ Hammertoe Fixation System indicated for the<br>fixation of osteotomies and reconstruction of the lesser toes<br>following correction procedures for hammertoe, claw toe, and<br>mallet toe. |
| Technological<br>characteristics: | The proposed device has the same technological characteristics as<br>the predicate devices. |
| Testing: | Performance testing consisted of tests for pull out, torque and static<br>and dynamic bend strength. |
| Conclusions: | The results of the comparison of design, materials, intended use and<br>technological characteristics demonstrate that the device is as safe<br>and effective as the legally marketed predicate devices. |