K-number	K260720
Device name	mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);
Applicant	MED-EL Elektromedizinische Geräte GmbH
Product code	ETB
Device class	Class II
Decision date	Apr 3, 2026
Decision	Substantially Equivalent
Regulation	874.3450

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The mWING Stapes Prosthesis is a partial ossicular replacement prosthesis made of medical-grade titanium used in middle ear surgery. It restores sound transmission to the oval window by replacing the stapes arch or stapes arch and incus in patients with fixed stapes footplate, otosclerosis, traumatic injury, or previous failed stapes surgery. The device is implanted by qualified ENT surgeons and is single-use, sterile.

Technological characteristics

The mWING has a narrower loop-band (0.30 mm vs. 0.50 mm) with added stabilizing wings, compared to the predicate mAXIS Stapes Prosthesis. Both share identical loop diameter (1.00 mm), loop opening (0.85 mm), shaft diameter (0.2 mm), manual crimping attachment, titanium material, 27 size variants, biocompatibility, and MRI conditional at 1.5/3.0/7.0 T. The narrower loop enables softer crimping while maintaining stable attachment via the stabilizing wings.

Test standards cited

MRI Safety (ASTM F2119, F2052, F2182); Biocompatibility (EN ISO 10993, FDA-2013-D-0350); Shelf-Life and Packaging (EN ISO 11607); Sterilization validation (EN ISO 11137-1, EN ISO 11137-2); Usability Testing (IEC 62366-1); Mechanical and Functional Bench Testing.

Substantial equivalence argument

The subject device and predicate are substantially equivalent because they have identical materials, manufacturing, sterilization, indications for use, and most design parameters. The only design modification—narrower loop-band with stabilizing wings—does not introduce new worst-case conditions and falls within previously validated configurations. Usability and mechanical bench testing confirmed ENT surgeons can safely manipulate and crimp the modified loop, and the design does not adversely affect safety or performance.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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