# ETA: Replacement, Ossicular Prosthesis, Total

- Device class: 2; regulation: 21 CFR 874.3495; FDA's rule: 510(k) required
- FDA decisions: 40
- 510(k) review time 2021–2025: median 268 days (middle half 268–268)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1997: 3
- 1998: 1
- 1999: 3
- 2000: 4
- 2003: 1
- 2004: 1
- 2005: 1
- 2009: 2
- 2025: 1
- 2026: 2

## Most-cited predicates
- K972585: Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis, Aerial Prosthesis, Model Tubingen (1997), cited by 4
- K042503: Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM (2004), cited by 2
- K241269: mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit (2025), cited by 1
- K993583: Zurich Titanium Ossicular Replacement System (1999), cited by 1

Source page: https://510kreport.com/product-code/ETA
Data by year (CSV): https://510kreport.com/product-code/ETA.csv