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HammerTech Fixation System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161449

by Fusion Orthopedics, Llc

Identifiers

510(k) Number
K161449 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The HammerTech Fixation System is a PEEK threaded bone implant designed for the fixation of the interphalangeal joints of the lesser toes. It is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The system is used to provide stable internal fixation during bone healing.

The device is supplied as a fixation system for orthopedic surgical use. It is cleared under FDA 510(k) with product code HWC and regulation number 888.3040. The system is intended for single-use in surgical procedures and is provided sterile. Storage conditions and MRI safety details are not specified in the available data.

Frequently asked questions

What is the HammerTech Fixation System used for?

It is a PEEK threaded bone implant designed to provide stable internal fixation for osteotomies and reconstruction of the interphalangeal joints of the lesser toes. It supports healing after surgical correction of hammertoe, claw toe, and mallet toe deformities.

How is the device supplied and what is its sterility status?

The system is supplied as a complete fixation kit for orthopedic surgical use. It is provided sterile and is intended for single-use only, meaning it must be discarded after one surgical procedure.

What material is the implant made from and why is that significant?

The implant is constructed from PEEK (polyether ether ketone), a high-performance thermoplastic known for its biocompatibility and modulus similar to bone. This material choice helps reduce stress shielding and provides radiolucent properties, which may improve post-operative imaging.

Is there any specific storage requirement mentioned for this device?

The available device data does not specify particular storage conditions, such as temperature or humidity limits. Users should consult the manufacturer's labeling or contact Fusion Orthopedics, LLC, for detailed storage instructions prior to use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FIXATION SYSTEM - HammerTech - Fusion Orthopedics, HammerTech Fixation System by Fusion Orthopedics, LLC | FDA 510 (k) Summary, PDF Microsoft Word - HammerTech Fixation Summary Rev D.docx, HammerTech Fixation System (K161449) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fusion Orthopedics, Llc

Sources (1)

  • FDA 510(k) K161449 24 fields · synced Sep 26, 2026