# K241261: mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit

- Pathway: 510(k) (Traditional)
- Applicant: MED-EL Elektromedizinische Geräte GmbH
- Decided: Jan 17, 2025 after 266 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: 2 generations back to K972492 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972492: Bell Prosthesis (Partial), Heinz Kurz (1997) Summary page 7.
- K990923: Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010, Heinz Kurz (1999) Summary page 7.
- K013573: Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257, Heinz Kurz GmbH Medizintechnik (2001) Summary page 7.

## Most influential descendants
- K260718: 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) (2026), 0 descendants of its own

## Indications for use
INTENDED USE: The passive middle ear implant – tympanoplasty partial prosthesis is intended to be used for replacement of components of the ossicular chain, if at least the stapes footplate is present and functional. The tympanoplasty 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 tympanoplasty prosthesis is a medical device for single use delivered in sterile condition. INTENDED USER The tympanoplasty 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 tympanoplasty prosthesis is indicated to treat patients with: - congenital or acquired ossicular chain defects (e.g., chronic otitis media, traumatic injury, malformation, cholesteatoma) - inadequate conductive hearing from previous middle ear surgery The partial ossicular replacement prosthesis is indicated, if at least the stapes head and its stapes footplate are present and functional. Tympanosplasty Sizers for partial prosthesis (Note that the tympanosplasty Sizers are packaged together with the mXACT PRO Partial Prosthesis conforming the mXACT PRO Partial Prosthesis Kit). INTENDED USE The tympanoplasty Sizers are intended to be used during a partial ossicular replacement surgery to determine the required functional length of the MED-EL tympanoplasty prosthesis. The tympanoplasty Sizers are optional, single-use surgical tools for intraoperative transient use only and delivered in sterile condition. The Sizers for partial prosthesis are intended to intraoperatively determine the distance between the head of the stapes and the tympanic membrane, thereby determining the required functional length of the MED-EL tympanoplasty prosthesis. INDICATIONS The indications of the PMEI tympanoplasty partial prostheses apply.

Source page: https://510kreport.com/device/K241261
Methodology: https://510kreport.com/methodology