(84 days)
Synthes (USA) Sternal Reconstruction System is intended for use in sternal repair and reconstruction.
The Synthes modified Sternal Reconstruction System contains a 1.0 mm stainless steel cable with detachable needle with ferrule The cable is 750 mm in length.
This is a 510(k) premarket notification for a medical device (a modification to a Sternal Reconstruction System), not a study analyzing device performance with acceptance criteria.
Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance, study details (sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance), or training/ground truth details.
The document is a regulatory submission summary stating that the device is substantially equivalent to a predicate device, based on comparative information. It does not describe new performance testing against specific acceptance criteria.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.