mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50

The mGRIP Total Prosthesis and mARC Total Prosthesis are passive middle ear implants used to replace ossicles in patients with ossicular chain defects. Both devices are single-use, sterile, total ossicular replacement prostheses (TORPs) made of medical-grade titanium that bridge the gap between the tympanic membrane and stapes footplate to restore sound transmission. They are implanted by qualified ENT surgeons in patients of all ages with congenital or acquired ossicular chain defects or inadequate hearing from previous ear surgery.

The mGRIP features an oval bendable headplate with integrated pre-bent spikes for stabilizing cartilage and reducing dislocation risk. The mARC features a round tiltable headplate with a ball-joint connection to allow tilting for anatomical alignment and improved intraoperative handling. Both have a staged or continuous shaft (0.20–0.25 mm diameter), cannulated footing, 13 length variants (3.0–7.0 mm), medical-grade titanium construction, and MRI conditional capability at 1.5, 3.0, and 7.0 T.

IEC 62366-1 (usability testing), EN ISO 10993 (biocompatibility), EN ISO 11607 (shelf-life and packaging), EN ISO 11137-1 and 11137-2 (sterilization validation), ASTM F2119, F2052, F2182 (MRI safety), and mechanical/functional bench testing.

Both subject devices are substantially equivalent to the predicate mXACT Total Prosthesis Offcenter because they share identical materials, manufacturing, sterilization, packaging, and most design parameters (shaft, coupling structure, attachment method). Design differences (spikes on mGRIP headplate; ball-joint and round headplate on mARC) were evaluated via usability and mechanical testing per IEC 62366-1, confirming safe and effective use. The mARC headplate design is identical to the already-cleared mCLIP ARC Partial Prosthesis, further supporting equivalence.