# ETB: Prosthesis, Partial Ossicular Replacement

- Device class: 2; regulation: 21 CFR 874.3450; FDA's rule: 510(k) required
- FDA decisions: 74
- 510(k) review time 2021–2025: median 267 days (middle half 266–267)
- 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)
- 1999: 4
- 2000: 8
- 2001: 2
- 2002: 1
- 2003: 1
- 2006: 3
- 2008: 1
- 2013: 2
- 2025: 2
- 2026: 2

## Most-cited predicates
- K972492: Bell Prosthesis (Partial) (1997), cited by 6
- K021479: Clip Piston Awengen, Model# 1006 805 - 1006 861 (2002), cited by 5
- K002221: Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170 (2000), cited by 4
- K003214: Smith & Nephew Pistons (2000), cited by 3
- K990923: Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010 (1999), cited by 3
- K061853: Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses (2006), cited by 2
- K033554: Smart Offset Stapes Piston; Smart Isj Prosthesis (2003), cited by 2
- K013573: Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257 (2001), cited by 1
- K991394: Stapes Prostheses (1999), cited by 1
- K130512: Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes Prosthesis (2013), cited by 1

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