(55 days)
The agp APS System is intended for use of fractures of femoral head (Hip Plates) and condylar part of the femur (Condylar Plates).
Specific indications, which are dependent in the angle of the plate, include:
- 125°-150°: fractures of the trochanter region, simple and multifragmentary pertrochanteric, intertrochanteric
- 95°: distal and intercondylar fractures of the femur
The implants for the aap APS System are manufactured of Titanium Alloy and Stainless Steel and are available for the femoral head and the condylar part of the femur. The titanium alloy and the stainless steel material is identical to the materials used in the predicate devices.
The aap System includes APS Plates with various angles (95° for condylar plates; 125°, 130°, 135°, 140°, 145° and 150° for Hip Plates), APS Lag Screws with various lengths from 50mm to 145mm, APS compression screws and instruments for implantation.
The provided text describes a 510(k) summary for the "APS-System," an autodynamic plate-screw system intended for bone fixation. However, the document does not contain information regarding the acceptance criteria, device performance, or any studies conducted to prove the device meets performance criteria.
The information provided only covers:
- Submitter and contact details
- Trade Name and Common/Usual Name
- Classification information
- Performance standards related to manufacturing (cGMP, ASTM, ISO) and material specifications (Titanium Alloy, 316L Stainless Steel, surgical grade Stainless Steel, Silicone, Propylux, Polyoxymethylene).
- Intended Use and Contraindications
- Device Description
- Predicate Devices for Substantial Equivalence
- Sterilization Information
- FDA regulatory correspondence (510(k) clearance letter and Indications for Use statement)
Therefore, I cannot extract any of the requested information about acceptance criteria or studies from 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.