(87 days)
The Osteo 5.0mm Cannulated Screw System is indicated for ligament fixation and long and small bone fracture fixation, which may include the following:
- Fixation of intermediate-sized fragments in fractures such as: .
- proximal and distal humerus fractures
- fractures of the olecranon process
- femoral fractures
- tibial plateau and metaphyseal fractures of the proximal and distal tibia
- medial and lateral malleolar and pilon fractures
- os calcis, talar, and patellar fractures -
- . Ligament fixation of the proximal humerus
- . Fractures of the pelvis and acetabulum
- . Arthrodesis of the tarsals
The Osteo 5.0mm Cannulated Screw System consists of 5.0mm thread diameter self-tapping cannulated screws of varying lengths and one washer, the use of which is optional. The 5.0mm screw has a thread diameter of 5.0mm, a shaft diameter of 3.2mm, a head diameter of 6.0mm, and a cannulation diameter of 2.0mm. The washer for the 5.0 screws has an outer diameter of 8.0mm, an inner diameter of 4.5mm, and a thickness of 1.0mm. The surfaces of the screws and washers are anodized with a Type II coating. The screws and washers are provided both sterile and non-sterile.
This is a 510(k) premarket notification for a medical device (Osteo 5.0mm Cannulated Screw System), not a study analyzing its performance against acceptance criteria. The document establishes substantial equivalence to predicate devices, which is the basis for FDA clearance in this pathway. Therefore, the requested information regarding acceptance criteria, device performance, study design, and specifics about ground truth and expert involvement is not available within this document.
The provided text describes the device, its intended use, and states its substantial equivalence to existing predicate devices (Synthes Titanium 4.5mm Cannulated Screw and ACE Medical Titanium Cannulated Screw and Reconstruction Plate System). The FDA's letter confirms this substantial equivalence determination, allowing the device to be marketed.
In a 510(k) submission seeking clearance based on substantial equivalence, detailed performance studies with acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness studies are typically not required in the same way they would be for a Premarket Approval (PMA) application or a clinical trial for a novel device. The FDA essentially determined that because this device is substantially equivalent to legally marketed devices, it can be presumed to be as safe and effective as those predicate devices.
§ 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.