The HammerTech® device 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 HammerTech® Fixation System implant is a polyetheretherketone (PEEK) threaded bone implant intended for fixation of the proximal interphalangeal (PIP) joint of the lesser toes. The PIP implant is comprised of two ends of a single, solid member. Each end slides into the prepared canal of the bone to be fused. The device is a straight cannulated design offered in four different sizes to address the wide variation of patient anatomy.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "HammerTech® Fixation System." It details the device's characteristics, intended use, and a summary of non-clinical tests performed to demonstrate substantial equivalence to predicate devices. Crucially, it states that no clinical studies were performed.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, because such a study was not conducted as part of this submission. The device's clearance was based on demonstrating substantial equivalence to existing devices through non-clinical testing, not on meeting specific performance acceptance criteria via clinical trials.

The information provided in the document relates to the regulatory submission process and the technical specifications required for market clearance, rather than a clinical performance study with acceptance criteria.

Summary

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

October 11, 2016

Fusion Orthopedics, LLC % J.D. Webb Consultant The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K161449

Trade/Device Name: HammerTech® 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: September 14, 2016 Received: September 20, 2016

Dear J.D. Webb:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/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/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,

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161449

Device Name

HammerTech® Fixation System

Indications for Use (Describe)

The HammerTech® device is indicated for the fixation of osteotomies 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)

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510(k) Summary: HammerTech® Fixation System

Date Prepared	October 3, 2016
Submitted By	Fusion Orthopedics, LLC4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-6876
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-mail: jdwebb@orthomedix.net
Trade Name	HammerTech® Fixation System
Common Name	Screw, Fixation, Bone
Classification Name	Smooth or threaded metallic bone fixation fastener.
Class	II
Product Code	HWC
CFR Section	21 CFR section 888.3040
Device Panel	Orthopedic
Primary PredicateDevice	HammerFiX, Extremity Medical, LLC (K133636)
Secondary PredicateDevice	K-wire, Trilliant Surgical (K121008)
Device Description	The HammerTech® Fixation System implant is a polyetheretherketone(PEEK) threaded bone implant intended for fixation of the proximalinterphalangeal (PIP) joint of the lesser toes. The PIP implant is comprised oftwo ends of a single, solid member. Each end slides into the prepared canalof the bone to be fused. The device is a straight cannulated design offered infour different sizes to address the wide variation of patient anatomy.
Materials	Polyetheretherketone (PEEK) (ASTM F2026)
SubstantialEquivalence Claimedto Predicate Devices	The HammerTech® Fixation System is substantially equivalent to thepredicate devices in terms of intended use, design, materials used,mechanical safety and performances.
Indications for Use	The HammerTech® device is indicated for the fixation of osteotomies andreconstruction of the lesser toes following correction procedures forhammertoe, claw toe and mallet toe.
Non-clinical TestSummary	The following analyses were conducted:● Static 4-point bending (ASTM F382)● Dynamic 4-point bending (ASTM F382)● Pull-out test (ASTM F543)● Torsion test (ASTM F543)● Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL)assay. The testing demonstrated that the subject device meets therecommended maximum endotoxin level of 20 EU per device.
	The results of these evaluations indicate that the HammerTech® FixationSystem is equivalent to predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions:Non-clinical andClinical	Fusion Orthopedics, LLC considers the HammerTech® Fixation System to beequivalent to the predicate devices listed above. This conclusion is basedupon the devices' similarities in principles of operation, technology, materialsand indications for use

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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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.