# K021479: Clip Piston Awengen, Model# 1006 805 - 1006 861

- Pathway: 510(k) (Special)
- Applicant: Heinz Kurz GmbH Medizintechnik
- Decided: May 21, 2002 after 13 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: 1 generation back to K002221 (2000). 1 ancestor in all.
8 later devices descend from it; 5 cite it directly.
0 of 10 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 2.

## Most influential descendants
- K042503: Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM (2004), 7 descendants of its own
- K063374: Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and Footplate Shoe (2006), 4 descendants of its own
- K112616: Nitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis (2013), 3 descendants of its own
- 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

## Indications for use
For bridging the stapes in case of otosclerosis;

Source page: https://510kreport.com/device/K021479
Methodology: https://510kreport.com/methodology