(107 days)
The Sulzer Orthopedics Sysorb Interference Screws are intended for use in the following diagnostic indications:
- Tibial and femoral fixation (primary anchorage) of the autologous tendon-transplants as it is used in the reconstruction of the cruciate ligaments of the human knee.
The Sulzer Orthopedics Sysorb Interference Screws are a bioresorbable interference screw used in attachment of autologous tendon tranfers in cruciate ligament reconstruction. The Sysorb interference screws are manufactured from the bioresorbable material Poly (D,L-Lactide) (Resomer R208), an amorphous polymer derivative of lactic acid. The screw provides an initial interference fit fixation of the tissue graft and resorbs over time as the graft is naturally incorporated into the surrounding structure.
The Sysorb Interference Screw uses a nearly symmetrical thread profile which takes into account both the strength of the material and the relative strength of cancellous bone. The design also allows the screw to be introduced without drilling or tapping. A continuous "turbine" shaped driving feature allows torque to be applied along the complete length of the screw upon implantation, thus minimizing the potential for fracture of the implant.
The provided document is a 510(k) summary for the Sulzer Orthopedics Sysorb Interference Screw. This type of document is for a medical device that does not perform diagnostic functions or involve AI. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and AI performance is not applicable to this submission.
The document discusses the product description, its intended use, and its substantial equivalence to other marketed resorbable interference screws. It also includes an FDA letter confirming the device's substantial equivalence.
In summary, none of the requested information about acceptance criteria, study design, expert ground truth, or AI performance can be extracted from this document as it pertains to a non-AI, non-diagnostic medical device.
§ 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.