The HammerFiX 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 HammerFiX device is a bone fixation device consisting of a sterile, threaded PEEK or titanium alloy implant and a set of instruments used for implant site preparation and delivery. The device is offered in extra small, small, medium and large implant sizes to allow for use in the proximal interphalangeal (PIP) joints of the lesser toes of the foot.

AI/ML Overview

This document describes a medical device called the HammerFiX Device, which is a bone fixation fastener used in foot surgery. It is a 510(k) premarket notification, which means it builds upon an already approved predicate device. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device rather than presenting a standalone study with acceptance criteria for a novel device.

Based on the provided document, the following information can be extracted:

Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states "No clinical testing was performed." and that "Bench testing, including pull-out, torque and bending was performed and compared to the predicate device." However, no specific acceptance criteria (e.g., minimum pull-out strength, maximum bending angle) or reported numerical performance values for this bench testing are provided in the summary. The conclusion simply states that the new device and predicate device are equivalent based on this testing.

Acceptance Criterion	Reported Device Performance	Comments
(Not explicitly stated for the device in this summary)	Performance was similar to the predicate device in pull-out, torque, and bending tests.	The document does not provide specific numerical values for acceptance criteria or performance for these bench tests. It only states that the new device was compared to the predicate device.

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. No clinical testing was performed, and the sample sizes for the bench testing are not provided.
- Data Provenance: Not applicable for clinical data. For bench testing, the provenance is that the tests were performed by the manufacturer, Extremity Medical, LLC.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

Not applicable. No clinical testing was performed, thus no ground truth was established by experts for a test set in the context of this 510(k) submission.
Adjudication Method for the Test Set:

Not applicable. No clinical testing was performed.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document explicitly states "No clinical testing was performed."
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a medical implant device, not an algorithm.
Type of Ground Truth Used:

Not applicable. No clinical testing was performed. For the non-clinical testing, the "ground truth" would be the measured mechanical properties of the predicate device against which the new device was compared.
Sample Size for the Training Set:

Not applicable. This is a medical implant device, and no algorithm with a training set is involved.
How the Ground Truth for the Training Set Was Established:

Not applicable. No algorithm with a training set is involved.

Summary of Device Rationale from the Document:

The HammerFiX Device is a PEEK or titanium alloy implant used for fixation of osteotomies and reconstruction of lesser toes. The current submission, K152710, is a "Special 510(k)." This typically means that the device is a modification of an already cleared predicate device (K133636 - HammerFiX by Extremity Medical). The manufacturer asserts substantial equivalence based on:

Identical indications for use.
Similar design.
Similar material mechanical properties.
Bench testing (pull-out, torque, and bending) which showed equivalence to the predicate device.
No clinical testing was deemed necessary for this 510(k) submission because it is demonstrating substantial equivalence to an existing, cleared device.

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other.

September 8, 2016

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

Extremity Medical, LLC Brian Smekal VP, Regulatory Affairs and Quality Assurance 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

Re: K152710

Trade/Device Name: HammerFix Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 18, 2015 Received: September 21, 2015

Dear Mr. Brian Smekal:

This letter corrects our substantially equivalent letter of October 15, 2015.

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 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

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device-related 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.

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,

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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See PRA Statement below.

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

Indications for Use

510(k) Number (if known)

K152710

Device Name HammerFiX Device

Indications for Use (Describe)

The HammerFiX 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)

2 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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Special 510(k) Summary of Safety and Effectiveness:

HammerFiX Device

Submitter:	Extremity Medical, LLC.300 Interpace ParkwaySuite 410Parsippany, NJ 07054
Contact Person	Brian Smekal, MS, RACVP, Regulatory Affairs and Quality AssurancePhone: (973) 588-8988Email: bsmekal@extremitymedical.com
Date Prepared	October 13, 2015
Trade Name	HammerFiX Device
Classification Nameand Number	Smooth or threaded metallic bone fixation fastener
Classification Nameand Number	21 CFR 888.3040
Product Code	HWC (screw, fixation, bone)
Predicate Devices	K133636 - HammerFiX (Extremity Medical)
Device Description	The HammerFiX device is a bone fixation device consisting of a sterile, threadedPEEK or titanium alloy implant and a set of instruments used for implant sitepreparation and delivery. The device is offered in extra small, small, medium andlarge implant sizes to allow for use in the proximal interphalangeal (PIP) jointsof the lesser toes of the foot.
Indications for use	The HammerFiX device is indicated for the fixation of osteotomies andreconstruction of the lesser toes following correction procedures for hammertoe,claw toe and mallet toe.
Statement ofTechnologicalComparison	The HammerFiX device and predicate devices are equivalent in terms ofindications for use, design, and material mechanical properties.
Non-clinical Testing	Bench testing, including pull-out, torque and bending was performed andcompared to the predicate device.
Clinical Testing	No clinical testing was performed.
Conclusion	The HammerFiX device is substantially equivalent to its predicate device. Thisconclusion is based upon indications for use, design, test data and principles ofoperation.

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.