# JDR: Staple, Fixation, Bone

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 233
- 510(k) review time 2021–2025: median 69 days (middle half 40–113)
- Recalls: 19 (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: 9
- 2018: 8
- 2019: 5
- 2020: 4
- 2021: 3
- 2022: 5
- 2023: 9
- 2024: 4
- 2025: 3
- 2026: 2

## Most-cited predicates
- K993714: Memograph Staple, Warm System (2000), cited by 18
- K070031: Memometal Memory Staples (2007), cited by 13
- K043059: Compression Staple and Simple Staple (2005), cited by 10
- K930892: Mitek Mini Anchor, Modification (1994), cited by 9
- K926384: Statak & Mini-Statak Soft Tissue Attachment Device (1993), cited by 9
- K142292: Speed, Speed Shift, Speed Titan, Speed Arc (2014), cited by 9
- K082215: Osteoraptor Suture Anchor (2008), cited by 8
- K001354: Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System (2001), cited by 7
- K964226: Memory Staple (20 Sizes Available) (1997), cited by 7
- K920213: Mitek Anchor, Mitek Anchor II (1992), cited by 7

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