(213 days)
The ARC Surgical Resorbable Compression Screw System is a bioabsorbable PLLA screw intended to provide fixation and/or reduction of bone fragments and bones. Specifically, as listed below, the screw is intended to fix osteochondral fragments, osteotomies and fractures in the foot, and limited fractures in the wrist, elbow, and ankle.
- . Osteochondral fragments
- Femoral condyle o
- Talus 0
- Navicular ্
- Hallux Valgus correction ●
- Tarsal fractures .
- Distal Radius fractures ●
- Radial Head fractures .
The ARC Surgical Resorbable Compression Screw System is composed of screws injection molded from poly-L-lactic acid (PLLA) with diameter (4.3mm to 4.8mm) and length (16mm to 24mm). Headless screw compression is obtained from the varying pitch of the threadless screw has a tapered square cannulation and the driver has a square-shaped geometry to drive the screw. The screws are provided sterile.
The provided document, K043176, is a 510(k) summary for the Arc Surgical Resorbable Compression Screw System. Based on the content, there are no acceptance criteria, performance data, or studies present in this document.
The document explicitly states:
"An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable."
This indicates that the device was approved based on its substantial equivalence to predicate devices, and no new performance studies were required or presented for this 510(k) submission. Therefore, it's not possible to provide the requested information regarding acceptance criteria and study details from this document.
§ 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.