# K260720: 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);

- Pathway: 510(k) (Special)
- Applicant: MED-EL Elektromedizinische Geräte GmbH
- Decided: Apr 3, 2026 after 29 days
- Product code: ETB (Prosthesis, Partial Ossicular Replacement)
- Device class: 2
- Regulation: 21 CFR 874.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K002221 (2000). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241142: mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis, MED-EL Elektromedizinische Geräte GmbH (2025) Summary page 5.

## Indications for use
INTENDED USE: The passive middle ear implant – stapesplasty prosthesis is intended to be used for replacement of the stapes arch or stapes arch and incus in case of a fixed stapes footplate. The stapesplasty prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. The stapesplasty prosthesis is a medical device for single use delivered in sterile condition. INTENDED USER The stapesplasty prosthesis is intended to be implanted by qualified ENT surgeons only, with adequate skills to perform otological surgeries. Replacement of the ossicular chain is a standard surgical procedure, no additional specific device training is mandatory or required for the safe and effective use. TARGET PATIENT POPULATION The target patient population for the passive middle ear implant are patients of all ages requiring reconstruction of the ossicular chain. INDICATIONS: The stapesplasty prosthesis is indicated to treat patients with: - congenital or acquired defects of the stapes due to e.g., otosclerosis, congenital fixation of the stapes, traumatic injury, malformation of the ossicular chain or middle ear - inadequate conductive hearing from previous stapes surgery

Source page: https://510kreport.com/device/K260720
Methodology: https://510kreport.com/methodology