# K990923: Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010

- Pathway: 510(k) (Special)
- Applicant: Heinz Kurz
- Decided: Mar 31, 1999 after 12 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 K972492 (1997). 2 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972492: Bell Prosthesis (Partial), Heinz Kurz (1997) Summary page 2.
- K972585: Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis, Aerial Prosthesis, Model Tubingen, Heinz Kurz GmbH Medizintechnik (1997) Summary page 2.

## Most influential descendants
- 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
- K241269: mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit (2025), 1 descendant of its own

## Indications for use
Ossicle replacement in case of interrupted sound conducting chain and intact mobile stapes between the tympanic membrane and the stapes foot plate. The Tuebingen Titanium Prosthesis (TIP) AERIAL VARIO is intended for bridging a complete auditory ossicle defect. Ossicle replacement in case of interrupted sound conducting chain and intact mobile stapes. The Tuebingen Titanium Prosthesis (TIP) BELL VARIO is intended for partial replacement of the auditory ossicles.

Source page: https://510kreport.com/device/K990923
Methodology: https://510kreport.com/methodology