# K972492: Bell Prosthesis (Partial)

- Pathway: 510(k) (Traditional)
- Applicant: Heinz Kurz
- Decided: Aug 4, 1997 after 33 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.
14 later devices descend from it; 6 cite it directly.
0 of 15 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 partial ossicular devices: named in the summary without a submission number
- (no number) Xomed partial ossicular devices: named in the summary without a submission number
- (no number) S&N Richards Applebaum Prosthesis: 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
For bridging defects at the long incudal process in patients with otherwise intact mobile chain. The Angular prosthesis (Plester) consists of two titanium bands which are connected by a gold wire to the bell with its cross-shaped slits. The bands function as clamps and are positioned on the long incudal process. In cases of arrosion at the distal end of the long incudal process, the prosthesis allows the reconstruction of the continuity of the auditory ossicular chain. By slight lateral displacement of one end of the bands overclosure is possible. Titanium ensures a firm connection with the bone. Ossicle replacement in case of interrupted sound conducting chain and intact, mobile stapes footplate. The Bell Prosthesis is intended for partial replacement of the auditory ossicles. The bell is mounted on the head of the stapes, i.e. interposed between stapes and ear drum or stapes and manubrium mallei. Should stapes head no longer exist, bell is placed on intact arch of Crus.

Source page: https://510kreport.com/device/K972492
Methodology: https://510kreport.com/methodology