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The OSTEOMED ICON Modular Locking Fixation System is indicated for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The OSTEOMED ICON Modular Locking Fixation System implants and drills are intended for single use onlv.

The OSTEOMED ICON Modular Locking Fixation System is comprised of plates, screws and instrumentation utilized in the fixation of maxillofacial and mandibular fractures. The screw and plate interface allows up to 20 degrees of angulation within screw placement. The plating system allows for the use of locking standard screws, locking Auto-Drive™ screws, standard non-locking screws, safety screws and Auto-Drive™ screws, as needed. The system features three modular blocks. - . The 1.6mm Midface System consists of 1.6mm locking standard screws with lengths ranging from 3mm to 14mm, 1.6mm locking Auto-Drive™ screws with lengths ranging from 4mm to 8mm and 1.9mm safety screws with lengths ranging from 3mm to 1.6mm midface plates range in thicknesses of 0.6mm to 0.8mm. - . The 2.0mm Midface/Mandible System consists of 2.0mm locking standard screws with lengths 4mm to 18mm, 2.0mm locking Auto-Drive™ screws with lengths of 4mm to 8mm, and 2.3mm safety screws with lengths ranging from 4mm to 24mm. The midface plates range in thicknesses of 0.6mm to 0.8mm and the mandible plates range in thicknesses of 1.0mm to 1.5mm. - The 2.8mm Mandible System consists of 2.0mm locking standard screws with lengths 6mm to 22mm, 2.4mm locking Auto-Drive™ screws with lengths of 6mm to 8mm, and 2.7mm safety screws with lengths ranging from 6mm to 22mm. The fracture plates range in thicknesses of 1.0mm to 1.5mm and the reconstruction plates range in thicknesses of 2.0mm to 2.8mm. The instruments include drill bits, plate bending pliers, plate holding forceps, plate cutters, drill guides, cannulae, taps, countersinks, and screwdrivers to facilitate the placement of screws and modification of plates.

OsteoMed Hand Fusion System is intended for use in bone fusion and arthrodesis of phalanges and metacarpals. It is intended for use in trauma, general surgery and reconstructive procedure. The OsteoMed Hand Fusion System implants are intended for single use only.

The OsteoMed Hand Fusion System consists of plates, fusion screws and surgical instruments. Plates and fusion screws are provided in various sizes. The implants are made of Titanium (ASTM F-67 or ASTM F-136) or Stainless Steel (ASTM F-138 or ASTM F-139). Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. These instrüments are made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.

The OsteoMED Low Profile Neuro Fixation System is indicated for use in osteotomies, fractures or reconstructions of the cranial bones. Implants and drills are single use only.

The OSTEOMED Low Profile Neuro Fixation System is comprised of plates, screws and instrumentation. The system features plates ranging from 0.25mm to 1.0mm thick, 1.2 mm to 1.6mm diameter standard screws in lengths from 2.0mm to 8.0mm and Auto-Drive screws in 1.2mm to 1.6mm diameters in lengths from 3.0mm to 8.0mm. The instruments include drill bits, plate bending forceps, plate holding forceps, plate cutters, cannulae, taps, countersinks and screwdrivers to facilitate the placement of screws and modification of plates. The screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.

The PrimaLOK™FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, degenerative disease of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.

The PrimaLOK™FF Facet Fixation System is a partially threaded, cannulated, self-tapping 4.5mm screw having an assembled, articulating washer. It is available in lengths from 25 to 45mm to accommodate differing anatomic requirements.

The PrimaLOKTM SP Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The PrimaLOKTM SP Interspinous Fusion System is intended for use at one level, with bone graft material and not intended for stand-alone use.

The PrimaLOKTM SP Interspinous Fusion System is a bilateral locking plate system which attaches to the spine at the spinous processes. It is available in various interspinous heights and widths to accommodate differing anatomic requirements.

The OsteoMed Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the device. The OsteoMed Foot Plating System implants are intended for single use only.

This submission describes the OsteoMed Foot Plating System consisting of various shape and sizes plates featuring compression, locking, elongated or compression elongated holes, and ulated locking, non-locking and cannulated screws, implantable K-wires, washers, and angulated instrumentation. The OsteoMed Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device. All implants are intended for single use only. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, , or other bones appropriate for the size of the device. The implants are made of Titanium (ASTM F-67, ASTM F-136, or ASTM F-1472) or Stainless Steel (ASTM F-138 or ASTM F-139). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.

OsteoMed Hand Plating System is intended for use in trauma, general surgery and reconstructive procedures of the hand, wrist, or other bones appropriate for the size of the device. The OsteoMed Hand Plating System implants are intended for single use only.

The OsteoMed Hand Plating System is a rigid fixation system consisting of plates and screws in various configurations. Plates are provided in a variety of shapes and sizes, and offer surgeons compression and locking hole designs. The Hand Plating System includes angulated locking, nonlocking, lag, and cannulated screws as well as a buttress pin and K-wire implants. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The implants are made of Titanium (ASTM F-67 or ASTM F-136) or Stainless Steel (ASTM F-138 or ASTM F-139). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.

The OsteoMed Metatarsal Resurfacing Implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; hallux limitus, hallux valgus, hallux rigidus, and an unstable or painful MTP joint. The OsteoMed Metatarsal Resurfacing Implant is intended to be used with bone cement or press fit without bone cement. The OsteoMed Metatarsal Resurfacing Implant is intended for single use only.

The OsteMed Metatarsal Resurfacing Implant is a one piece implant designed to replace the distal head of the metatarsal and provides a smooth articular surface for the adjacent phalangeal base. The implant is available in several sizes in direct proportion to the anatomic construct of the metatarsal head.

The OsteoMed Modular Locking Fixation System is intended for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The OsteoMed Modular Locking Fixation System implants and drills are intended for single use only.

The OSTEOMED Modular Locking Fixation System is comprised of plates, screws and instrumentation utilized in the fixation of craniofacial, maxillofacial and mandibular fractures. The locking screw and plate interface allows up to 20 degrees of angulation within screw placement. The plating system allows for the use of locking standard screws, locking Auto-Drive™ screws, standard nonlocking screws, safety screws and Auto-Drive™ screws, as needed. The screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). Drill bits, plate bending pliers, plate holding forceps, plate cutters, drill guides, cannulae, taps, countersinks, and screwdrivers to facilitate the placement of screws and modification of plates will also be a part of the system.

The OsteoMed Metatarsal Resurfacing Implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful MTP joint. The OsteoMed Metatarsal Resurfacing Implant is intended to be used with bone cement or press fit without bone cement. The OsteoMed Metatarsal Resurfacing Implant is intended for single use only.

The OsteoMed Metatarsal Resurfacing Implant is a one piece implant designed to replace the distal head of the metatarsal and provides a smooth articular surface for the adjacent phalangeal base. The implant is available in several sizes in direct proportion to the anatomic construct of the metatarsal head. Primary fixation is intended to be used with bone cement or press fit without bone cement.