# K972585: Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis, Aerial Prosthesis, Model Tubingen

- Pathway: 510(k) (Traditional)
- Applicant: Heinz Kurz GmbH Medizintechnik
- Decided: Aug 4, 1997 after 25 days
- Product code: ETA (Replacement, Ossicular Prosthesis, Total)
- Device class: 2
- Regulation: 21 CFR 874.3495
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Smith & Nephew Richards: named in the summary without a submission number
- (no number) Xomed (with Tonos): named in the summary without a submission number

## Most influential descendants
- K990923: Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010 (1999), 11 descendants of its own
- K061853: Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses (2006), 6 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

## Indications for use
Ossicle replacement in case of interrupted sound conducting chain and intact, mobile stapes footplate. The Aerial Total Prosthesis is intended for bridging a complete auditory ossicle defect. The prosthesis is placed on the basis of the stapedis and the defect is bridged as far as the ear drum or up to the manubrium mallei.

Source page: https://510kreport.com/device/K972585
Methodology: https://510kreport.com/methodology