# HTO: Reamer

- Device class: 1; regulation: 21 CFR 888.4540; FDA's rule: 510(k) exempt
- FDA decisions: 14
- Recalls: 72 (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)
- 1983: 1
- 1986: 1
- 1987: 1
- 1989: 1
- 1990: 1
- 1995: 1
- 2000: 1
- 2001: 1
- 2005: 1
- 2011: 1

## Most-cited predicates
- K993335: Synthes Reamer/Irrigator/Aspirator (Ria) System (2000), cited by 1
- K042899: Synthes (Usa) Ria System - Expanded Indications (2005), cited by 1

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