Device Dossier

Orthopaedic implant inserter/extractor, single-use

Device Dossier for Orthopaedic implant inserter/extractor, single-use (Orthopaedic implant inserter/extractor, single-use, Class IIa, sponsor…

Intended purpose

A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a single-use device.

TGA Public Summary