(90 days)
The Dolphin Medical Technologies DRG Large Screw™ System will be used on indications that are common with presently marketed devices. The indications for use of the DRG Large Screw™ System reconstruction of intra-anicular epiphyseal and of metaphyseal fractures. Specifically, intracapsular fractures of the hip, slipped capital femoral epiphyses, tibial plateau fractures, distal femoral condyle fractures, ankle, elbow and shoulder fractures where indicated.
The DMT DRG Large Screw™ System will be offered in Ti-GAL-4V ELL It will be available in common styles and assorted lengths for bone fraction and stabilization. Initially, a range of twenty-four screw lengths will be made available in 6.5 mm diameter (25-120 mm). Screw types are implantable using a standard (e.g. American Orthopedic) hexhead screwcriver, which is cannulated at center.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance metrics. The document is a 510(k) submission for the DRG Large Screw™ System, focusing on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed performance study data against defined acceptance criteria.
The document mentions:
- Performance Standards: "No performance standards applicable to the Bone Screw have been established by the FDA."
- Material Standards: The titanium alloy used meets ASTM F136-84, and the general material and design meet ASTM B348-83, F136-84, F67. This refers to material specifications, not device performance criteria in a clinical or mechanical test context.
- Substantial Equivalence: The core of the submission is asserting that the product is "substantially equivalent in design, composition and function to other orthopedic screws manufactured and approved for market" and lists several predicate devices.
Therefore, I cannot extract the specific details you requested because they are not present in 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.