# PLF: Bone Wedge

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 18
- 510(k) review time 2021–2025: median 88 days (middle half 30–106)
- Recalls: 3 (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)
- 2015: 2
- 2017: 2
- 2019: 2
- 2020: 2
- 2021: 1
- 2022: 2
- 2023: 1
- 2024: 3
- 2025: 2
- 2026: 1

## Most-cited predicates
- K193414: Trigon HA Stand-Alone Wedge Fixation System (2020), cited by 5
- K201314: Restor3d Utility Wedge (2021), cited by 4
- K220197: Trigon HA Wedge Fixation System (2022), cited by 3
- K151256: Arthrex BioSync® Bone Wedge (2015), cited by 3
- K203445: Trigon HA Stand-Alone Wedge Fixation System (2020), cited by 2
- K162241: TITAN 3-D™ Wedge System (2017), cited by 2
- K240461: OsteoSinter® EVANS and COTTON wedges and related accessories (2024), cited by 2
- K243231: Trigon PEEK HA Wedges (2024), cited by 1
- K192645: Trigon™ Ti Stand-Alone Wedge Fixation System (2019), cited by 1
- K171327: Tyber Medical Wedge System (2017), cited by 1

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