(90 days)
This device is indicated for use in the general management of fractures and reconstructive surgery in non-weight bearing applications with proper postoperative immobililzation.
Bone-Lok™ Bioabsorbable Compression Anchor with Titanium Fixture and Bone-Lok™ Bioabsorbable Compression Anchor
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the Bone-Lok™ Bioabsorbable Compression Anchor, indicating that the device is substantially equivalent to legally marketed predicate devices.
The letter discusses regulatory aspects, such as compliance with the Federal Food, Drug, and Cosmetic Act, and general controls like good manufacturing practice and labeling. However, it does not detail specific performance characteristics, acceptance criteria, or any studies undertaken to demonstrate the device's efficacy or safety in relation to such criteria. The "Indications For Use" section merely states the general purpose of the device.
Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance or information about a study based on the provided text.
§ 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.