(164 days)
The Accelerate Compression Screw System is indust and skeletally mature pediatic patients (aged 12-21 years), for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
The Trax Accelerate Compression Screw System is intended to be used to treat fracture and reconstruction of the small bones of the extremities (hands and feet). The screws are manufactured from 6AL-4V titanium and are anodized in various colors for easy size recognition. Washers will be provided for some screw sizes as appropriate. The fixation screws come in three (3) different configurations, headed, headless and break away. The headed and headless screws are cannulated. The breakaway screws are solid. They vary in diameter and length to allow the surgeon to select the appropriate device for the patient's anatomy. All devices are intended to be provided in an autoclavable instrument tray that includes a set of Class I instruments. The set will be provided non-sterile to the end user. The surgical instruments are intended to prepare the site and fixate the screws. The screws and instruments shall be designed to be maintained in an autoclavable tray. Replacement implants and instruments will be available separately as required.
The provided text is a 510(k) Summary for the Trax Surgical Accelerate Compression Screw System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies or AI algorithm evaluation.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.
Instead, it addresses the following for the Accelerate Compression Screw System:
- Indications for Use: For fracture repair and fixation, osteotomy, joint fusion, reconstruction, and arthrodesis of bones appropriate for the device size, in adult and skeletally mature pediatric patients (12-21 years).
- Performance Data (Non-Clinical): Evaluated according to ASTM F543-17 and FDA guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers. Static torsion (torque to failure), Insertion/Removal torque, and Axial pullout testing were performed to demonstrate substantial equivalence to predicate devices.
- Biocompatibility: Demonstrated using materials that meet applicable standards and/or are used in 510(k) cleared devices (K172383).
- Technological Characteristics: Similar to predicate devices in indications for use, materials and coatings, function, and range of sizes.
- Predicate Devices: Captivate Compression Screws (K222409), GEO Bone Screw System (K202817), Treace Medical Concepts Snap-off Screw System (K183363). A reference device is Arthrosurface Bone Screws (K172383).
In summary, this document is a 510(k) submission and primarily relies on non-clinical performance data and technological characteristics to assert substantial equivalence to existing devices, not on human clinical trials or AI algorithm performance against acceptance criteria.
§ 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.