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The OsteoMed Cannulated Screw System is indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.

The OSTEOMED Cannulated Screw System is comprised of screws and washers used for bone fixation of the hand and foot following trauma or osteotomy. The System features cannulated screws in the following dimensions: 2.0mm screw diameter - 6mm to 42mm screw length; 2.4mm screw diameter - 6mm to 52mm screw length; 3.0mm screw diameter - 10mm to 40mm screw length; 3.5mm screw diameter - 12mm to 52mm screw length; 4.0mm screw diameter - 12mm to 52mm screw length; 5.5mm screw diameter - 12mm to 52mm screw length; 6.5mm screw diameter - 20mm to 120mm screw length; 8.0mm screw diameter - 30mm to 140mm screw length; The implants (screws and washers) of the OsteoMed Cannulated Screw System are made from Titanium alloy (ASTM F-136). Modifications to screws and washer of the subject system include redesign of the 4.0mm cannulated screw to increase the strength of the lag portion and addition of a 3.0mm diameter cannulated screw and washer. The system instruments include depth gauges, screw drivers, drills, countersinks, k-wires, and preparation instruments to facilitate the placement of screws. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.

Intended for the re-attachment of the bone flap after a craniotomy. The OsteoMed Cranial Flap Fixation System is intended for single patient use only.

This submission describes the OsteoMed Cranial Flap Fixation System intended for the re-attachment of the bone flap after a craniotomy. The OsteoMed Cranial Flap Fixation System is intended for single patient use only. The OsteoMed Cranial Flap Fixation System is a clamping device which has a threaded post attached to an inferior disk and a threading superior disk that threads down the post to secure a sandwich fit of the Cranial Flap and cranium between the inferior and superior plate. The device locks into place once the desired fixation is achieved by the surgeon. The OsteoMed Cranial Flap Fixation devices are available in a range of 10mm to 22mm disk diameters.

Indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; angular deformity; impaired function and stability; pain; impaired toe length ratio. Implants are single use only.

This submission describes the OsteoMed Interphalangeal Flexible Stabilizing Rod System intended for indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; anqular deformity; impaired function and stability; pain; impaired toe length ratio. OsteoMed Interphalangeal Flexible Stabilizing Rod Implants are intended for single use only. The OsteoMed Interphalangeal Flexible Stabilizing Rod System is a stemmed flexible implant specifically designed for replacement of the interphalangeal joints of the lesser toes. It is constructed of medical grade silicone elastomer. The OsteoMed Interphalangeal Flexible Stabilizing Rods are offered in diameters of 2.0mm through 2.5mm. Drills and sizers will also be a part of the system.

Indicated for partial or complete dislocation of the lesser metatarsophalangeal joint; pain associated with either rheumatoid or osteoarthritis; repair for unsuccessful arthroplasties of the lesser metatarsophalangeal joint; stiffness at the lesser metatarsophalangeal joint associated with joint disease; hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state. Implants are single use only.

The OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System is a stemmed flexible implant specifically designed for replacement of the lesser metatarsophalangeal joints of the foot. It is constructed of medical grade silicone elastomer. The OsteoMed Metatarsophalangeal Flexible Stabilizing Rods are offered in diameters of 2.5mm through 3.0mm. Drills and sizers will also be a part of the system.

Indicated for fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand. 1.2mm Auto-Drive Screws are intended for single patient use only.

The OsteoMed 1.2mm Auto-Drive Screw System is comprised of 1.2mm diameter screws in lengths ranging from 3.0mm to 6.0mm. System instruments include screwdrivers and driver bits.

Indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia. The OsteoMed Intraoral Mandibular Distraction System is intended for single patient use only.

The OsteoMed Intraoral Mandibular Distraction System is a subcutaneous bone distractor. It features various curved and straight bars activated with a threaded wire that has screw holes that are fixed to bone via 1.6mm/2.0mm bone screws. The distractor is available in two sizes and in right and left versions. The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 35mm.

OsteoMed OSA Rigid Internal Fixation System is intended for a variety of pan facial indications. Specifically, the system is intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and mandible. Implants are single use only.

The OsteoMed OSA Rigid Internal Fixation System is comprised of various plates and screws. Plates, .8mm through 1.0mm thick, are provided in various shapes and sizes. Screws are provided in 1.6mm and 2.0mm diameter in lengths of 4.0mm through 8.0mm. Safety screws are 1.9mm and 2.4mm diameter. Depth gauges, screwdrivers, countersinks, pilot drills, and preparation instruments will also be a part of the system.

Indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital areas, comminuted fractures of the frontal sinus wall and midfacial fractures, and reconstructive procedures of the midface or craniofacial skeleton. The OsteoMed Bioresorbable Fixation System is not intended for use in and is contraindicated for: the mandible and/or full load bearing procedures; in cases of active or suspected infection or in patients who are immunocompromised; in cases where there is limitation of the blood supply or inadequate volume or quality of bone to place the system securely; in patients exhibiting disorders which would cause the patient to ignore the limitations of rigid fixation.

The OsteoMed Bioresorbable Fixation System is comprised of various plates, meshes and screws. Plates and meshes, 0.5mm through 1.2mm thick, are provided in various shapes and sizes. Screws are provided in 1.6mm diameter in lengths of 4.0mm through 8.0mm. Safety screws are 2.0mm diameter in lengths of 4.0mm through 8.0mm. The implanted components of the device are manufactured from 70:30 poly L/D,L-lactide.