# LXH: Orthopedic Manual Surgical Instrument

- Device class: 1; regulation: 21 CFR 888.4540; FDA's rule: 510(k) exempt
- FDA decisions: 58
- Recalls: 378 (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)
- 1990: 8
- 1992: 5
- 1993: 1
- 1994: 7
- 1995: 2
- 1996: 1
- 2000: 1
- 2010: 1
- 2014: 1
- 2019: 1

## Most-cited predicates
- K792670: Smith Subtalar Peg (1980), cited by 3
- K192873: SX-One MicroKnife (2019), cited by 1
- K943873: Orthomet Anatomically Guided Carpal Tunnel Release SY (1995), cited by 1
- K902819: Laminectomy Rogeur (1990), cited by 1
- K140414: Imbibe Needle (2014), cited by 1

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