ToeTac Hammertoe Fixation System

• K Number: K150443
• Device Name: ToeTac Hammertoe Fixation System
• Manufacturer: RESTORE SURGICAL LLC dba Instratek
• Date Cleared: 2015-06-04 ( 104 days)
• Product Code: HWC
• Regulation Number: 888.3040
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K133636 , K112254
• Predicate For: K161778

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 Description

The Instratek ToeTac™ Hammertoe Fixation System includes a threaded PEEK implant for bone fixation and a set of instruments used for implant site preparation and delivery. The device is offered in a sterile packaged kit that contains the implant, bone preparation instrumentation and a driver.

AI/ML Overview

This document is a 510(k) premarket notification for the ToeTac™ Hammertoe Fixation System. It confirms that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices.

The document contains information about the device's intended use, classification, and a summary. However, it does not contain information regarding acceptance criteria and a study proving the device meets those criteria, as typically seen in a comprehensive device validation report. Instead, it briefly mentions "Performance testing consisted of tests for axial pull out, torque, static and dynamic bend." without providing details of the acceptance criteria or quantitative results.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: Not explicitly stated in the document.
   • Reported Device Performance: The document only generally states, "Performance testing consisted of tests for axial pull out, torque, static and dynamic bend." No specific quantitative performance data or comparison to acceptance criteria is provided.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • This information is not provided in the document.

3. 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)

   • This information is not applicable as the document describes performance testing for a medical device (fixation system), not a diagnostic or AI-driven decision support system where "ground truth" would be established by experts for a test set.

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

   • This information is not applicable for mechanical performance testing of a fixation system.

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

   • This information is not applicable as the device is a hammertoe fixation system, not an AI diagnostic tool.

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

   • This information is not applicable as the device is a hammertoe fixation system, not an AI algorithm.

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

   • For performance testing of a mechanical device, "ground truth" typically refers to engineering standards or predicate device performance, not clinical ground truth established by experts or pathology. Details are not provided.

8. The sample size for the training set

   • This information is not applicable as the device is a mechanical fixation system, not an AI model requiring a training set.

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

   • This information is not applicable as the device is a mechanical fixation system, not an AI model requiring a training set.

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

June 4, 2015

Restore Surgical, LLC dba Instratek Mr. Jeff Seavey President 15200 Middlebrook Drive, Suite G Houston, Texas 77058

Re: K150443

Trade/Device Name: ToeTacTM 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: April 30, 2015 Received: May 1, 2015

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Jeff Seavey

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 [phone] or [phone] 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 [phone] or [phone] 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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SECTION 006: INDICATIONS FOR USE STATEMENT

510(k) Number: K150443

ToeTac™ Hammertoe Fixation System Device Name:

Indications for 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.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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SECTION 007: 510(K) SUMMARY

Submission Correspondentand Owner:	Restore Surgical LLC, dba Instratek15200 Middlebrook Dr., Suite GHouston, TX 77058USA
	281-890-8020Phone:Fax: [phone]Email: [e-mail]: Mr. Jeff SeaveyPresident
Date summary prepared:	February 17, 2015
Device trade name:	ToeTac™ 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	HammerFiX, K133636Kirschner Wire, K112254
Description of the device:	The Instratek ToeTac™ Hammertoe Fixation System includes athreaded PEEK implant for bone fixation and a set of instrumentsused for implant site preparation and delivery. The device is offeredin a sterile packaged kit that contains the implant, bone preparationinstrumentation and a driver.
Intended use of the device:	The ToeTac™ Hammertoe Fixation System indicated for thefixation of osteotomies and reconstruction of the lesser toesfollowing correction procedures for hammertoe, claw toe, andmallet toe.
Technologicalcharacteristics:	The proposed device has the same technological characteristics asthe predicate devices.
Testing:	Performance testing consisted of tests for axial pull out, torque,static and dynamic bend.
Conclusions:	The results of the comparison of design, materials, intended use andtechnological characteristics demonstrate that the device is as safeand effective as the legally marketed predicate devices.

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.