(17 days)
The FreeFix Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.
The FreeFix Forearm Plating System is comprised of plates, screws and specific instrumentation. The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.
The provided document is a 510(k) premarket notification letter and summary for the Skeletal Dynamics FreeFix Forearm Plating System. This document DOES NOT contain information about acceptance criteria and study that proves the device meets the acceptance criteria in the format requested.
The document states:
- "Mechanical testing, which established equivalency, includes ASTM F543-23, Standard Specifications and Test Methods for Metallic Bone Screws. All acceptance criteria were met, and the FreeFix Forearm Plating System performed better than its predicate device."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used or their qualifications.
- Adjudication method.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on standalone algorithm performance.
- The type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
This document focuses on establishing substantial equivalence to a predicate device based on mechanical testing (ASTM F543-23) for bone screws and does not describe clinical performance studies with human readers or AI.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.