(58 days)
Specific indications for use of the subject devices in Wrist Fixation System are as follows: TriMed Volar Plates and Radial Peg Plates:
Fractures, non-unions or osteotomies of the distal radius.
TriMed Ulnar Peg Plates:
Fractures, non-unions and osteotomies of the distal end of the ulna.
TriMed Pin Plates:
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Fractures of the radial column of the wrist.
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Fractures of the dorsal ulnar cortex of the distal radius.
TriMed Wire Forms, Shear Plates and Hook Plates
Fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone.
TriMed Radial Osteotomy System is indicated for osteotomies of the distal radius.
TriMed Welded Wire Forms in Wrist Fixation System 3 is indicated for Fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone.
TriMed Volar Bearing Plates and Volar Fixed Angle Plates consist of anatomically shaped plates used for fractures, non-unions or osteotomies of the distal radius. Volar Bearing Plates utilize distal bearings to allow peg angulation. Volar Fixed Angle Plates have pre-defined peg-hole trajectories. TriMed Fixed Angle and Bearing Plates are compatible with 2.3mm locking pegs and 2.3mm nonlocking cortical bone screws distally and 3.2mm screws proximally.
TriMed Wrist Hook Plates are anatomically shaped plates used for fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone. TriMed Wrist Hook Plates are compatible with 2.3mm screws and locking pegs.
TriMed Pin Plates are anatomically shaped plates used for the treatment of the radial column of the wrist and fractures of the dorsal ulnar cortex of the distal radius. TriMed Pin Plates are compatible with 1.1mm k-wires and 2.3mm screws.
TriMed Radial Peg Plates are anatomically shaped for the radial column used for fractures, nonunions or osteotomies of the distal radius. TriMed Radial Peg Plates are compatible with 2.3mm screws and locking pegs. TriMed Ulnar Peg Plates are semi-tubular straight plates used for fractures, non-unions and osteotomies of the distal end of the ulna. TriMed Unar Peg Plates are compatible with 2.3mm screws and locking pegs.
TriMed Shear Plates are anatomically shaped plates used for fragments of the distal radius. TriMed Shear Plates are compatible with 2.3mm screws.
TriMed Wire Forms are contoured to be used for fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone. TriMed Wire Forms are used with washers or wireform plates and 2.3mm threaded pegs and 2.3mm screws. TriMed Welded Wireforms have a welded washer that accept 2.3mm screws.
TriMed Radial Osteotomy Plates are used to perform osteotomies of the distal radius. TriMed Radial Osteotomy Plates have pre-defined peg-hole trajectories. TriMed Radial Osteotomy Plates are compatible with 2.3mm locking pegs and 2.3mm non-locking cortical bone screws distally and 3.2mm screws proximally.
All implants are made from 316L Stainless Steel per ASTM F138/139 and are supplied non-sterile.
The provided text describes a 510(k) premarket notification for the TriMed Wrist Fixation System and related devices. It does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is for a traditional medical device (implants and screws) and explicitly states: "Clinical studies were not conducted for the subject devices."
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets those criteria from this document.
§ 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.