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CERAMENT G is a resorbable, gentamic bone void filler intended for use in defects in the extremntes of skeletally mature patients as an adjunct to systemic antibiotic therapy and surgical debridement as part of the standard treatment approach to bone infection and open fractures. By eluting gentamicin, CERAMENT G can reduce the occurrence of bone infection from gentamicinsensitive microorganisms in order to protect bone healing. CERAMENT G can augment provisional hardware to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. CERAMENT G resorbs and is replaced by bone during the healing process.

CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. It is composed of hydroxyapatite, calcium sulfate and gentamicin, and is identical to the device cleared in DEN210044. This submission expands the device's indication to include use in patients with open fractures in need for bone void filling.

The OSTEOMED ExtremiFuse System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The OSTEOMED ExtremiFuse System is indicated for small bone reconstruction limited to interdigital repair and fusion of the phalanges. The ExtremiFuse implant is a one piece implant with a threaded portion and a barbed portion that holds the resected faces of the two phalanges together. The implant is offered in 4 diameter sizes of 2.0mm, 2.0mm and 4.0mm. For each size, the implant is available in angle configurations of 0° and 10°. The system instruments include guide wires, broaches, cannulated drills, and implant drivers to facilitate the placement of the implants. The ExtremiFuse implants are made from implant grade titanium alloy (Ti6Al4V) per ASTM F136. The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.