Device Dossier
Orthopaedic fixation plate, non-biodegradable
Device Dossier for Orthopaedic fixation plate, non-biodegradable (Orthopaedic fixation plate, non-biodegradable, Class IIb, sponsor DePuy Synthes). ARTG…
- GMDN category: Orthopaedic fixation plate, non-biodegradable
Intended purpose
An implantable sheet of firm material that is attached to fractured bone fragments with screws (via holes or threaded locking holes) to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals. The material is not chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium (alloy), or carbon fibre]. The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).