(28 days)
The Arthrex Compression Staple 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 Arthrex Compression Staple is a metal staple offered in five sizes.
The provided document is a 510(k) Summary for the Arthrex Compression Staple (K080111). This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies usually associated with AI/software devices.
The information provided focuses on:
- Manufacturer/Distributor/Sponsor: Arthrex, Inc.
- Trade Name: Arthrex Compression Staple
- Common Name: Fixation Staple
- Product Code - Classification Name: JDR - Single/multiple component metallic bone fixation appliances and accessories
- Predicate Device: Wright Medical Compression Staple, K043059
- Device Description and Intended Use: A metal staple in five sizes for various bone fixation procedures in the foot.
- Substantial Equivalence Summary: States that the Arthrex Compression Staple is substantially equivalent to the predicate Wright Medical Compression Staple, with basic features and intended uses being the same, and any differences being minor and not raising safety/effectiveness concerns.
In summary, there is no clinical study described in this 510(k) summary that evaluates medical device performance against specific acceptance criteria in the manner requested. The 510(k) process for this type of hardware device typically relies on demonstrating equivalence through comparison of design, materials, and mechanical properties, not through extensive clinical trials with human participant data and ground truth analysis as would be relevant for software-as-a-medical-device (SaMD) or AI-based systems.
§ 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.