(139 days)
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.
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.
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.
§ 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.