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TriMed Ulnar Osteotomy Plates are indicated for use in osteotomy procedures of the Ulna.

TriMed Ulnar Osteosystem System includes plates and screws indicated for osteotomies of the ulna. TriMed Ulnar Osteotomy System plates and screws are manufactured from medical grade stainless steel. Ulnar Osteotomy Compression Plates accept 3.2mm locking and non-locking screws. The lag screw hole in the plate accepts a 3.2mm lag screw that helps achieve additional compression across the osteotomy site.

The TriMed Fifth Metatarsal System is indicated for use in stabilization of fractures, malunions and non-unions of the fifth metatarsal.

The TriMed Fifth Metatarsal System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and non-unions that lend themselves to the principle of plate and/or screw fixation. The TriMed Fifth Metatarsal System consists of fixation plates and screws as well as stand-alone screws. The TriMed Fifth Metatarsal System implants are made from implant grade stainless steel.

The TriMed® Small Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot. The TriMed® Large Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of large bones and large bone fragments in the hand, wrist, elbow, ankle, and foot.

TriMed Compression Screws consists of small and large cannulated compression screws made of medical grade stainless steel and titanium. The small screws are indicated to be used as an aid in fracture fixations, non-unions and osteotomies of small bones and small bone fragments; the large screws are indicated to be used in fracture fixations, non-unions and osteotomies of large bones and large bone fragments. The TriMed Compression Screws are designed to provide additional constraint of movement of a fractured/osteotomized bone and non-unions and are intended only as an aid to fix the fracture/osteotomy in place during the healing process.

The following are osteosynthesis configurations that may be applicable to the TriMed Fusion Cups and Screws: 1. Arthrodesis of joints in the midfoot 2. Arthrodesis of the wrist and hand

The TriMed Fusion Cup System is used as an aid to the treatment of certain types of small bone arthrodesis. Fusion cups are manufactured from implantable medical grade polyetheretherketone (PEEK) and allow biaxial locking of screws. The cups are designed to be used with TriMed 2.4mm compression screws made of Ti6Al-4V ELI. Variation in implant size, diameter, and shape are intended to allow the implants to accommodate differences in patient size and sites of application. This special 510(k) is submitted to allow market release of additional sizes of fusion cups and compression screws.

The following fracture configurations may be applicable for treatment using TriMed Elbow and Forearm System: 1. Fractures, malunions and non-unions of the radius and ulna amenable to plate and/or screw fixation where the size, shape and location of the fractured bone are appropriate for the specific implant(s) used. 2. Fractures and osteotomies of the olecranon.

The TriMed® Elbow and Forearm System, comprising of bone plates, wire forms and screws, are intended to be used as an aid to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of plate and/or screw, wire form, tension band, or pin fixation. The TriMed Elbow and Forearm System plates, wire forms and screws are designed to provide additional constraint of movement of a fractured fused or osteotomized bone and are intended only as an aid to fix the fracture in place during the healing process.

The TriMed Sidewinder and Cluster Plates are indicated for fractures, non-unions & osteotomies of the distal fibula. The TriMed Straight Plates and Ankle Hook Plates are indicated for fractures, non-unions & osteotomies of the distal fibula and distal tibia. The TriMed Medial Malleolar Sleds and 4.0 Cannulated Compression Screws are indicated for fractures, non-unions & osteotomies of the Medial Malleolus of the distal tibia.

TriMed Ankle Fixation System (AFS) is a comprehensive ankle fracture fixation system intended to aid the treatment of certain types of fractures, malunions, and non-union of the tibia and fibula. The system is designed to constraint movement between bone surfaces and is intended only as an aid to fix the fracture in place during the healing process. The system implants consist of plates, screws and wire form devices and supporting instrumentation. The implants vary in designs, and sizes to accommodate patient size, anatomy and fracture type. The implants manufactured from 316L medical grade stainless steel per ASTM F138 or F139.

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: 1. Fractures of the radial column of the wrist. 2. 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.

TriMed Posterior Malleolus Fixation System is indicated for fractures, osteotomies, and non-unions of the distal tibia.

TriMed Posterior Malleolus Fixation System plates and screws are manufactured from medical grade stainless steel. Posterior Malleolar L-Plates and T-Plates accept 2.7mm and 3.2mm locking and non-locking screws.