(25 days)
The Synthes 3.0 mm PC-Fix™ is a long bone and small bone plate and screw system, intended to treat fractures of various bones, including the radius, ulna, distal tibia, pelvis, clavicle, fibula, humerus, and scapula.
The Synthes 3.0 mm PC-FixTM is a plate and screw system. The plate shares normal weight-bearing forces/load with the fixed fractured bone. and is fixed to the bone with locking screws, bridging the fracture as it heals. The plate neutralizes most of the torsional, shear and bending forces that would otherwise be transferred to the fracture site. This system is designed to be less invasive, as stripping of the periosteum is not recommended; reduce the risk of infection, refracture, implant failure, and loss of reduction (and subsequent complications); allow for early weight-bearing and carly implant removal; and reduce surgery time (no screw measuring, simpler procedure). The plates are available as Straight. T-shaped, and Reconstruction in commercially pure titanium. The screws are available in titanium alloy.
This document is a 510(k) summary for the Synthes 3.0 mm PC-Fix™ System, a bone plate and bone screw system. It declares that the device is substantially equivalent to a predicate device and is approved for marketing.
It does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria.
The document details:
- Device Description: The Synthes 3.0 mm PC-Fix™ is a plate and screw system designed to share normal weight-bearing forces with fractured bone, fixed with locking screws to bridge the fracture as it heals. It neutralizes torsional, shear, and bending forces. It's designed to be less invasive, reduce infection risk, allow early weight-bearing and implant removal, and reduce surgery time. The plates are available in Straight, T-shaped, and Reconstruction designs in commercially pure titanium; screws are titanium alloy.
- Intended Use: To treat fractures of various bones, including the radius, ulna, distal tibia, pelvis, clavicle, fibula, humerus, and scapula.
- Materials: Plates from commercially pure titanium, screws from titanium alloy.
- Predicate Device: Synthes PC-Fix.
- Regulatory Classification: Class II, 21 CFR 888.3030 and 888.3040.
- Warnings and Restrictions: The device is not approved for pedicular screw attachment or fixation to the posterior elements of the cervical, thoracic, or lumbar spine. If used for such purposes, it's considered investigational.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment from the provided text.
§ 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.