(202 days)
The JMEA cannulated bone screws are used to provide interference fixation of soft tissue grafts in anterior and posterior cruciate ligament repair through arthroscopy or arthrotomy.
The titanium alloy screw is cylindrical with a tapered tip and has smooth single or double belix thread design. The JMEA cannulated bone screws are and to provide interference fixation of soft tissue grafts in anterior and posterior cruciate ligament repair through arthroscopy or arthrotomy. The screw comes in various lengths and diamsters, resulting in a screw design adapted to the graft norphology and patication anatomy.
The provided text is for a 510(k) Pre-market Notification for the JMEA Cannulated Bone Screw System, which is a medical device for orthopedic fixation. This document is related to regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than a study evaluating the performance or diagnostic accuracy of an AI or software device.
Therefore, the information typically requested in your prompt (acceptance criteria, device performance tables, sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.) is not present in this type of regulatory submission.
This 510(k) summary focuses on:
- Device identification: Name, type, classification.
- Intended use: Fixing soft tissue grafts in ACL/PCL repair.
- Material: Titanium alloy.
- Design: Cannulated, tapered tip, smooth single/double helix thread.
- Substantial equivalence: Comparing the new device to existing, legally marketed predicate devices (Arthrex, Linvatec, Future Medical Systems, Acufex screws) based on design, intended use, application, and material. The claim is that there are no significant differences that would adversely affect safe use.
The FDA's letter confirms that they have reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices. This type of clearance does not typically involve the kinds of performance studies you're asking about, especially for an inert implant like a bone screw, where mechanical testing and material biocompatibility are usually the primary "performance" aspects considered for equivalence.
§ 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.