# K861369: Incus/Stapes Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Richards Medical Co., Inc.
- Decided: Jul 14, 1986 after 94 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.
34 later devices descend from it; 1 cites it directly.
0 of 35 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
- K042516: Otomimix (2004), 33 descendants of its own
- K060061: Stryker Injectable Cement (2006), 30 descendants of its own
- K161447: HydroSet XT (2016), 10 descendants of its own
- K060763: Stryker Injectable Cement (2006), 8 descendants of its own
- K173008: SCS 17-01 (2017), 4 descendants of its own

Source page: https://510kreport.com/device/K861369
Methodology: https://510kreport.com/methodology