# K130512: Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Heinz Kurz GmbH Medizintechnik
- Decided: Dec 2, 2013 after 278 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: 5 generations back to K002221 (2000). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002221: Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170, Heinz Kurz GmbH Medizintechnik (2000) Summary page 1.
- K021479: Clip Piston Awengen, Model# 1006 805 - 1006 861, Heinz Kurz GmbH Medizintechnik (2002). Our OCR of the scanned summary read K021478, FDA’s number for Delta Shoulder (Depuy, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CliP® Piston”.
- K112616: Nitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis, Heinz Kurz GmbH Medizintechnik (2013) Summary page 1.
- K002897: Titanium Middle Ear Prostheses, Xomed, Inc. (2000) Summary page 1.
- (no number) Big Easy: named in the summary without a submission number

## Most influential descendants
- 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
KURZ middle ear prostheses are intended for the partial or total surgical replacement of the ossicular chain of the human middle ear. The objective is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing. Specifically, the devices are designed for the treatment of 1. Chronic middle ear inflammation (also following removal of a tumor, e.g. cholesteatoma) with functional impairment of the ossicular chain 2. Otosclerosis (stapedial fixation) / congenital stapedial fixation 3. Traumatic injury to the ossicular chain 4. Malformation of the middle ear 5. Revision surgery to correct inadequate hearing improvement, e.g. through dislocation of a prosthesis

Source page: https://510kreport.com/device/K130512
Methodology: https://510kreport.com/methodology