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For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.

The modified Hybrid Endopore Implant also are identical to the predicates, except for the addition of three selftapping threads in the coronal region of the implant. The dimensions of the modified Hybrid Endopore Implant, 9.5 mm and 11 mm in length x 4.0 mm diameter; and 7.5 mm and 9.5 mm in length x 5.0 mm diameter, are very similar to the dimensions of previously cleared Endopore implants.

The Telescopic Distractor is an intraoral, subcutaneous distractor which is used for mandibular distraction osteogenesis. The device is indicated for use in patients with congenital micrognathia, post-traumatic mandibular deformities, or defects resulting from tumor resection. In conjunction with osteotomy or corticotomy, the Telescopic Distractor may be used for: - mandibular body lengthening; . - mandibular ramus lengthening; - distraction osteogenesis across a mandibular segmental defect in the ramus, body, or symphysis; and - transport distraction osteogenesis across a mandibular segmental . defect in the ramus, body, or symphysis.

Innova Corporation requests marketing clearance for the Telescopic Distractor, an intraoral subcutaneous device that permits either unilateral lengthening of the mandible. The device consists of forward and rear telescoping bodies that are held together by a central element. The subject device is designed with a central element that can be moved in opposing directions by turning an adjustment screw, producing the telescopic action. The telescoping bodies are attached to the inferior border of the mandibular osteotomy with bone plates and screws. The telescopic elements slide freely in the central element. The maximum amount of distraction possible between the two sections is 18 millimeters. A circular pin and a separate adjustment screw attaches the forward telescoping element to the forward bone plate. The circular pin provides a rigid, interlocking connection because of the snug fit within the opening in the forward telescoping element. The forward bone plate can be moved transversely relative to the telescopic elements by the adjustment screw. The rear telescopic element is similarly connected to the rear bone plate. The forward and rear bone plate elements are secured to the mandible with four bicortical stainless steel bone screws. Following placement of the distractor, the clinician waits for a period of 5 to 10 days to allow for intraoral healing prior to initiating distraction. The Innova Telescoping Distractor is made from wrought surgical grade stainless steel. The material conforms to ASTM F 138-97. This material is currently used in a variety of implanted devices such as bone plates and has a demonstrated biocompatibility by its long history of use for implant applications. The Telescoping Distractor is available in two models; unilateral and bilateral. The devices are operated and applied in an identical manner, except that the unilateral model is intended for distraction osteogenesis of either the right or the left side of the mandible. while the bilateral model is intended to be used for simultaneous distraction osteogenesis of both the right and left sides of the mandible.