(179 days)
Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.
The AlignMATE™ Lapidus Arthrodesis System consists of bone plates and bone screws (locking, non-locking and interfragmentary), which are intended to be used for surgical fusion or arthrodesis between two bone segments (ex. 1st metatarsalcuneiform fusion as in a Lapidus procedure). All implant components are manufactured from implant grade titanium alloy.
This document is a 510(k) premarket notification for a medical device (AlignMATE™ Lapidus Arthrodesis System), not an AI/ML medical device. Therefore, the information requested in your prompt regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, and ground truth establishment, is not applicable to this document.
This document describes a traditional medical device (bone plates and screws) and proves its substantial equivalence to previously cleared predicate devices based on:
- Indications for Use: The new device has the same intended uses as the predicate devices.
- Operating Principle: It functions in the same way.
- Materials: It is made from the same implant-grade titanium alloy.
- Instrumentation: It uses similar tools for placement.
- Packaging and Sterilization: These processes are consistent with the predicate devices.
- Non-clinical Testing: Mechanical testing (bending, torsional, insertion/removal, pullout) per ASTM standards and a bacterial endotoxins test were performed to demonstrate performance comparable to predicate devices.
There is no mention of any AI/ML component in the AlignMATE™ Lapidus Arthrodesis System, nor any AI/ML performance study conducted or referenced in this FDA submission.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.