# K002221: Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170

- Pathway: 510(k) (Traditional)
- Applicant: Heinz Kurz GmbH Medizintechnik
- Decided: Aug 9, 2000 after 16 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
No predicates in its family tree.
9 later devices descend from it; 4 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021479: Clip Piston Awengen, Model# 1006 805 - 1006 861 (2002), 8 descendants of its own
- 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

Source page: https://510kreport.com/device/K002221
Methodology: https://510kreport.com/methodology