# K112616: Nitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Heinz Kurz GmbH Medizintechnik
- Decided: Feb 8, 2013 after 519 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: 4 generations back to K002221 (2000). 13 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003214: Smith & Nephew Pistons, Gyrus Ent LLC (2000) Summary page 1.
- K063374: Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and Footplate Shoe, Grace Medical, Inc. (2006) Summary page 1.
- K021479: Clip Piston Awengen, Model# 1006 805 - 1006 861, Heinz Kurz GmbH Medizintechnik (2002) Summary page 1.

## Most influential descendants
- K130512: Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes Prosthesis (2013), 2 descendants of its own
- K241142: mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis (2025), 1 descendant of its own
- 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); (2026), 0 descendants of its own

## Indications for use
The prostheses are intended for partial ossicular replacement to restore functionality to the middle ear in cases of pathological changes of the sound transmission system. The NiTiBOND Stapes Prosthesis act as a bridge between the long process of the incus and the base of the stapes, with the piston extending into the perilymphatic space of the inner ear. The loop consists of a nickel-titanium alloy (Nitinol), while the piston is made of pure titanium. Specifically, the devices are designed for the treatment of 1. Otosclerosis (stapedial fixation) / congenital stapedial fixation 2. Traumatic injury to the ossicular chain 3. Malformation of the middle ear 4. Revision surgery to correct inadequate hearing improvement, e.g. through dislocation of a prosthesis

Source page: https://510kreport.com/device/K112616
Methodology: https://510kreport.com/methodology