(250 days)
The Inton OTPS™ Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue, e.g. bone grafts, bone graft substitutes, or bone fragments position of weak bony chsode, eightsm Biodegradable Mesh Plating System is also indicated for cement restriction in total joint arthroplasty procedures.
Only when used in conjunction with traditional rigid fixation, the Inion OTPSTM Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue in trauma and reconstructive orthopaedic procedures involving the following:
- Long bones
- Flat bones
- Short bones
- · Irregular bones
- · Appendicular skeleton
- Thorax
When used alone (without traditional rigid fixation), the Inion OTPS™ Biodegradable when used arone (without and to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopaedic procedures involving:
· Tumor resections where bone strength has not been compromised.
- · Iliac crest harvest sites.
The Inion OTPS™ Biodegradable Mesh Plating System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures.
The Inion OTPS™ Biodegradable Mesh Plating System is composed of various size mesh Internation associated fixations screws made of resorbable polylactic acid / pianes and associate a copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. The Inion OTPS™ Biodegradable Mesh Plating System implants armlually lose their strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.
This document describes the Inion OTPS™ Biodegradable Mesh Plating System. However, it does not contain any information regarding acceptance criteria, device performance, or any studies involving test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance of an AI algorithm.
The provided K031961 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on intended use, principles of operation, and mechanical testing. It does not include the type of performance study details requested in the prompt, which are typically associated with devices that involve diagnostic or predictive algorithms.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study to prove acceptance, as this information is not present in the provided text.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.