(335 days)
The Trident Extremity Fixation System consisting of plates and screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bone of the feet, hand, ankle and toes. Specific examples include:
- Arthrodesis of the first metatarsalcuneiform joint (Lapidus fusion procedure)
- Arthrodesis of the first metatarsalphalangeal joint (MTP fusion procedure)
- Primary and revision MTP fusion due to hallux rigidus and/or hallux valgus corrections
- Revision of failed first MTP arthroplasty implant 2nd, 3rd and 4th metatarsal weil osteotomy correction indications
- Metatarsal osteotomies to correct hallux valgus bunion indications
- Fractures of the fifth metatarsal bone in the foot
- Carpal bone fusions and fractures
Flatfoot Osteotomies: - Lateral column lengthening (Evans osteotomy)
- Plantar flexion opening wedge osteotomy of the medial cuneiform (Cotton osteotomy)
- Medial displacement calcaneal osteotomy
Midfoot/Hindfoot Arthrodesis/Fusions - Lisfranc arthrodesis and/or stabilization
- 1st, 2nd, 3rd and 4th Tarsometatarsal (TMT) fusions
- Navicular-Cuneiform (NC) joint fusions
- Talo-Navicular (TN) joint fusions
- Calcaneo-Cuboid (CC) joint fusions
- Medial column fusions (NC and 1st TMT)
The Trident Extremity Fixation System screws and plates are indicated for use with the Trident Plates and Screws of the same material. The locking and non-locking solid cortical screws, cannulated screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device.
The Subject device is manufactured from titanium conforming to ASTM F-136. The system includes plates in various sizes as well as locking and non-locking screws to be used with the plates. The bones screws are available in diameter sizes from 3.0 mm to 7.3 mm diameter and lengths from 10 mm to 100 mm. The system also includes reusable instrumentation for delivery of the implantable components. The Subject device has a similar range of sizes as its predicate.
This document describes the Trident Extremity Fixation System. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria from an AI/algorithm perspective. The provided text is a 510(k) premarket notification for a medical device and focuses on establishing substantial equivalence to predicate devices based on intended use, indications for use, materials, technological characteristics, and bench testing of mechanical properties.
Therefore, I cannot provide the requested information. The document is about a physical orthopedic fixation system, not a device involving AI or machine learning that would have performance metrics like sensitivity, specificity, or human-in-the-loop improvements.
§ 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.