(116 days)
The CHARLOTTE™ LisFranc Bone Screw is intended to be used for fixation such as: LisFranc arthrodesis, first metatarsophalangeal arthrodesis, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
The CHARLOTTE™ LisFranc Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
The CHARLOTTE™ LisFranc Bone Screw is offered in 2 diameters and a range of lengths to accommodate variability among patients. All screws are made from stainless steel.
The CHARLOTTE™ LisFranc Plate consists of plates, non-locking screws, and locking screws. All components are manufactured from stainless steel.
The provided text is a 510(k) summary for a medical device (bone screw and plate) and does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for AI/ML-based diagnostic devices.
The document focuses on establishing substantial equivalence to predicate devices, which is a different regulatory pathway than proving performance against specific acceptance criteria through a clinical or analytical study.
Therefore, I cannot provide the requested information. The document explicitly states:
- "The safety and effectiveness of the CHARLOTTE™ LisFranc Bone Screw and CHARLOTTE™ LisFranc Plate are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification." (Page 1, Section C)
This implies that the submission relies on demonstrating similarity to already approved devices rather than presenting novel performance data from human or AI-based evaluations.
§ 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.