(98 days)
The Self-Compressive Screws are intended for the fixation of bone fractures and for bone reconstruction in forefoot surgery.
The Self-Compressive Screw consists of screws available in several diameters and lengths. All the implants are made of titanium alloy. The fixation is provided thanks to the threading of the screw, which allows compression.
The provided document K131471 is a 510(k) summary for a medical device (Self-Compressive Screw). It explicitly states that no clinical studies were performed (Section VII, Page 3).
Therefore, I cannot provide information on acceptance criteria, reported device performance, sample size, data provenance, expert details, adjudication methods, MRMC study results, or training set specifics, as these are typically associated with clinical performance evaluations.
The document focuses on demonstrating substantial equivalence to a predicate device (Newclip Foot and Hand Motion System K091118) based on non-clinical mechanical tests:
- Resistance to torsion according to ASTM F543 – Annex 1
- Pull-out strength according to ASTM F543 Annex 3.
The conclusion (Section VIII, Page 4) states that "NEOSTEO considers the current Self-Compressive Screw to be equivalent to the predicate device listed above. This conclusion is based on the devices' similarities in principles of operation, technology, materials and indications for use."
Given the lack of clinical studies, the acceptance criteria and study details you requested are not available in this 510(k) 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.