(189 days)
The BIOTRAK™ Pin is intended for use in fixation and/or alignment of fragments and fractures of non-load bearing bones, osteotomies, arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities.
The ARC Surgical BIOTRAK TM Pin System is composed of pins injection molded from poly-L-lactic acid (PLLA) with diameter 1.5mm to 2.0mm and length 20mm to 40mm. External features on the pin provide increased resistance to loosening of bone fragments. The screws are provided sterile.
This document is a 510(k) summary for the ARC Surgical BIOTRAK™ Pin System. It describes a medical device, specifically a bioabsorbable bone fixation pin, and asserts its substantial equivalence to previously marketed devices. The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., performance metrics, sample sizes, ground truth establishment, or comparative effectiveness studies).
Instead, the document states:
"A discussion of clinical and non-clinical tests is not applicable."
And further:
"Based upon the similarities of the ARC Surgical BIOTRAK™ Pin System and the predicate devices studied, the safety and effectiveness of the BIOTRAK.™ Pin is substantially equivalent to the predicate devices referenced."
This indicates that the device's approval was based on demonstrating substantial equivalence to existing predicate devices, rather than on new performance studies with specific acceptance criteria. This is a common pathway for 510(k) clearances, where new clinical or non-clinical performance data is not always required if the device is sufficiently similar to legally marketed devices.
Therefore, I cannot provide the requested information. The document explicitly states that a discussion of clinical and non-clinical tests is not applicable for this submission.
§ 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.