Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.

This trial is a multi-center, single arm, historically controlled, pivotal device study. All participants diagnosed with osteomyelitis of the extremities (Cierny-Mader Classification grades I-IV) can be considered. All participants will undergo surgical debridement and will receive genex with gentamicin (genex G) antibiotic loaded bone void filler as part of the surgical treatment of osteomyelitis of the extremities. Participants will receive antibiotics per site specific requirements as clinically indicated. All participants will be followed up for 24 Months.