(30 days)
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
The Biomet Headless Compression and Twist-Off Screws consist of bone screws of various lengths and diameters and dimensionally optimized corresponding instruments which are used to aid in the alignment and stabilization of fractures to the skeletal system. The Biomet Headless Compression Screws are a cannulated headless screw, which is inserted below the bone surface. The Biomet Headless Compression Screw helps minimize soft tissue irritation and provides compression due to a dual thread design. The Biomet Twist-Off Screw is a solid one piece screw that has a direct connection to a drill or large diameter pin driver; this allows the screw to breakoff cleanly upon contact. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves automatic compression at the osteotomy site. The purpose of this submission is to introduce two new drivers to be used with the Biomet Headless Compression Screws with a decreased tip-taper length and increased radius of curvature compared to the drivers cleared in K142658.
This is a 510(k) premarket notification for a medical device, specifically bone fixation screws. The document does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study related to AI/ML performance.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them from this document. The document primarily focuses on demonstrating substantial equivalence of the new screw drivers to previously cleared predicate devices through non-clinical performance testing (torque testing, insertion/removal torque tests).
§ 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.