(180 days)
The Arthrex Compression FT pins (1.9 mm) are intended for small bone fracture and osteotomy fixation in the hand, wrist, foot, ankle and knee.
The Arthrex Compression FT pins (2.4 mm) are intended for fixation of small bone fragments, osteochondral fragments and cancellous fragments. Specific applications include the following:
- Osteochondral fragments
- Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal)
- Cancellous fragments
- Carpal, metacarpal, and small hand bone
- Tarsal and metatarsals
- Phalanges
- Intra-articular fractures
- Ankle
- Proximal and distal humerus
- Proximal and distal radius
- Proximal and distal ulna
- Osteochondral fixation and fractures
- Osteochondritis Dissecans
- Fixation of fractures and osteotomies about the knee
- Oblique fractures of the fibula
- Reconstructive surgeries of the foot
- Malleolar fixation
The Arthrex Compression FT Pins are a family of solid, fully threaded, self-tapping, tapering head with and without a snap-off function designed to provide fixation of fractures, osteotomies and arthrodesis. The pins are offered in two diameters: 1.9 mm and 2.4 mm, and range in lengths from 10 mm to 50 mm. The pins are manufactured from Titanium Alloy, conforming to ASTM F136. The pins are sold sterile and non-sterile and are single use.
This document is a 510(k) summary for a medical device (Arthrex Compression FT Pins), which focuses on establishing substantial equivalence to previously cleared devices. It does not describe a study involving an AI/ML device for which the listed criteria (e.g., acceptance criteria for diagnostic performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, MRMC studies) would be relevant.
The performance data presented in this document pertains to mechanical and material testing of the physical pins, as well as biocompatibility and MRI compatibility. It is demonstrating that the new pins perform similarly to existing, cleared implants.
Therefore, I cannot provide the requested information because the provided text describes the regulatory clearance of a physical medical device (bone fixation pins), not an AI/ML powered device. The types of studies and acceptance criteria asked for (e.g., related to AI performance, human reader improvement, ground truth for AI models) are completely irrelevant to the information contained in this 510(k) summary.
§ 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.