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 consists of PEEK (Polyetheretherketone (ASTM F2026)) and titanium alloy (Ti6Al4V ELI (ASTM F136)) threaded bone implants intended for fixation of the interphalangeal joint of the lesser toes. The device is offered in three configurations; straight cannulated PEEK, straight cannulated titanium, and angled solid titanium. Each configuration is offered in five different sizes to address to a variety of patient anatomy. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899). The implant and associated instrumentation is supplied sterile and non-sterile.

AI/ML Overview

This document is a 510(k) premarket notification for the HammerTech™ Fixation System, a bone fixation device. As such, it does not contain any information about a study proving that an AI/software device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

Intended Use: Fixing osteotomies and reconstructing lesser toes for hammertoe, claw toe, and mallet toe correction.
Design & Materials: PEEK and titanium alloy threaded bone implants, offered in various configurations and sizes.
Mechanical Safety and Performance: Non-clinical tests like static/dynamic 4-point bending, pull-out, torsion, and insertion torque were conducted to show equivalence to predicate devices, and pyrogenicity was evaluated.
No Clinical Studies: The document explicitly states, "No clinical studies were performed."

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and reported device performance for an AI/software.
Sample sizes or data provenance for an AI/software test set.
Number of experts or their qualifications for ground truth establishment for an AI/software.
Adjudication method for an AI/software test set.
MRMC comparative effectiveness study for AI assistance.
Standalone performance of an AI algorithm.
Type of ground truth used for AI.
Sample size for the training set for AI.
How ground truth for the training set was established for AI.

The document pertains to a physical medical device (bone fixation system) and its mechanical and material properties, not an AI or software-as-a-medical-device (SaMD).

Summary

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November 23, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Fusion Orthopedics, LLC Eli Jacobson Authorized Contact Person 4135 S. Power Rd.. Suite 110 Mesa, Arizona 85212

Re: K182684

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 20, 2018 Received: September 26, 2018

Dear Eli Jacobson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website

(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali -S

for

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: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K182684

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)

✔ Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

Date Prepared	November 23, 2018
Submitted By	Fusion Orthopedics, LLC4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-6876
Primary Contact	Eli Jacobson4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-6876 Telee-mail: eli@fusionorthopedics.com
Trade Name	HammerTech™ Fixation System
Common Name	Screw, Fixation, Bone
Class	II
Product Code	HWC
CFR Section	21 CFR section 888.3040
Device Panel	Orthopedic
Primary PredicateDevice	HammerTech™ Fixation System, Fusion Orthopedics (K161449)
SecondaryPredicate Device	PHALINX Hammertoe System, Wright Medical Technology, Incorporated (K150252) K-Wire, Trilliant Surgical (K121008)
DeviceDescription	The HammerTech Fixation System consists of PEEK (Polyetheretherketone (ASTMF2026)) and titanium alloy (Ti6Al4V ELI (ASTM F136)) threaded bone implants intended forfixation of the interphalangeal joint of the lesser toes. The device is offered in threeconfigurations; straight cannulated PEEK, straight cannulated titanium, and angled solidtitanium. Each configuration is offered in five different sizes to address to a variety of patientanatomy. The specialized instruments are made primarily of surgical grade stainless steel(ASTM F899). The implant and associated instrumentation is supplied sterile and non-sterile.
Indications forUse	The HammerTech device is indicated for the fixation of osteotomies and reconstruction ofthe lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
Materials	Ti-6Al-4V alloy (ASTM F136)Stainless steel (ASTM F899)Polyetheretherketone (ASTM F2026)
SubstantialEquivalenceClaimed toPredicate Devices	The HammerTech Fixation System is substantially equivalent to the predicate devices interms of intended use, design, materials used, mechanical safety and performances.
Comparison ofTechnologicalCharacteristics	The design of the HammerTech Fixation System is similar in shape to the predicate deviceswith a proximal threaded portion along with a distal barbed portion. HammerTech implantsare fabricated from Polyetheretherketone (PEEK) or titanium alloy whereas the primarypredicate is offered in only PEEK. The HammerTech Fixation is offered in smaller sizingthan the primary predicate device. The HammerTech Fixation can be steam sterilized orsterile packaged whereas the primary predicate can only be provided sterile packed.
Non-clinical TestSummary	The following analyses were conducted:Static 4-point bending (ASTM F382 Annex 1) Dynamic 4-point bending (ASTM F382 Annex 2) Pull-out test (ASTM F543 Annex 3) Torsion test (ASTM F543 Annex 1) Insertion Torque (ASTM F543 Annex 2) Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay. Thetesting demonstrated that the subject device meets the recommended maximumendotoxin level of 20 EU per device. The results of these evaluations indicate that the HammerTech Fixation System isequivalent to the predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions:	Fusion Orthopedics LLC considers the HammerTech Fixation System to be equivalent tothe predicate devices listed above. This conclusion is based upon the devices' similarities inprinciples of operation, technology, and indications for use. The non-clinical data supportsthat the HammerTech Fixation System should perform as intended in the specified useconditions and perform comparably to the predicate devices that are currently marketed forthe same intended use.

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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.