Device Dossier
Osteoset Resorbable Bead Kit - Standard Cure - Bone matrix implant, artificial
Device Dossier for Osteoset Resorbable Bead Kit - Standard Cure - Bone matrix implant, artificial (Bone matrix implant, synthetic, Class III, sponsor…
- GMDN category: Bone matrix implant, synthetic
- Sponsor: Stryker
Intended purpose
Intended to be gently packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseus defects created from traumatic injury to the bone. Osteoset pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.
Functional description
The kits contain a vial of calcium sulfate, a vial of sterile saline, a spatula and bowl for mixing, and a bead template. The single-use mold for the larger kit consists of two pieces which produce up to 30 beads of approx 7mm in diameter. A groove in the template allows the surgeon to link the beads with a suture, if desired. The single-use mold for the smaller kit will produce 200, 3.0mm or 50, 4.8mm diameter beads. The biodegradable, radiopaque pellets are resorbed in 30-60 days.