# HRX: Arthroscope

- Device class: 2; regulation: 21 CFR 888.1100; FDA's rule: 510(k) required
- FDA decisions: 685
- 510(k) review time 2021–2025: median 107 days (middle half 66–247)
- Recalls: 81 (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)
- 2017: 4
- 2018: 12
- 2019: 12
- 2020: 7
- 2021: 7
- 2022: 3
- 2023: 4
- 2024: 6
- 2025: 9
- 2026: 7

## Most-cited predicates
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A (2004), cited by 23
- K981251: Kyphon Inflatable Bone Tamp (1998), cited by 14
- K954465: FMS Duo (1995), cited by 12
- K971059: Universal Drive System (1997), cited by 11
- K953695: Dyonics Disposable Arthroscopic Blades (1995), cited by 11
- K990524: E9000 System (1999), cited by 11
- K943450: Arthrocare Arthroscopic Electrosurgery System Model 970 (1995), cited by 11
- K051827: Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys Laminoscope/Multiscope (2005), cited by 8
- K002931: Metrx System (2000), cited by 8
- K010246: Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A (2001), cited by 8

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