mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)

The mGRIP Partial Prosthesis and mDISC Partial Prosthesis are passive middle ear implants used to reconstruct the ossicular chain in patients with congenital or acquired ossicular defects or inadequate hearing from previous surgery. Both devices bridge the gap between the tympanic membrane and stapes head, restoring sound transmission. They are single-use, sterile titanium prostheses implanted by qualified ENT surgeons.

mGRIP features an oval headplate with integrated spikes for cartilage stabilization, a 0.2 mm shaft, and 10 length variants (0.75–3.5 mm). mDISC is shaftless with a round headplate (2.6 mm diameter) and a single 0.2 mm length variant. Both use medical-grade titanium (ASTM F67), share identical bell-shaped coupling structures, and are MRI conditional at 1.5, 3.0, and 7.0 T.

IEC 62366-1 (usability testing), ASTM F2119/F2052/F2182 (MRI safety), EN ISO 10993 (biocompatibility), EN ISO 11607 (shelf-life and packaging), EN ISO 11137-1 and 11137-2 (sterilization validation), and FDA guidance FDA-2013-D-0350.

Both devices are substantially equivalent to the predicate mXACT Partial Prosthesis because they share identical materials, manufacturing, sterilization, and packaging. Design modifications (spikes on mGRIP; shaftless round headplate on mDISC) do not introduce new worst-case conditions. Usability testing confirmed safe handling and effectiveness, and bench testing demonstrated increased lateral stability for mGRIP and device integrity for mDISC.