Device Dossier
Craniofacial fixation plate kit, non-biodegradable
Device Dossier for Craniofacial fixation plate kit, non-biodegradable (Craniofacial fixation plate kit, non-biodegradable, Class IIb, sponsor DePuy…
- GMDN category: Craniofacial fixation plate kit, non-biodegradable
Intended purpose
A collection of small plates and distractors (e.g. Midface, cranial, orbital, strut, mesh, locking, mandible and orthognathic) and bone screws, of various shapes/sizes, that are implanted onto fractured craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium (alloy), or carbon fibre). Instrumentation for implantation may be included. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.