# JDX: Instrument, Surgical, Sonic And Accessory/Attachment

- Device class: 2; regulation: 21 CFR 888.4580; FDA's rule: 510(k) exempt
- FDA decisions: 23
- 510(k) review time 2021–2025: median 283 days (middle half 283–283)
- Recalls: 0 (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)
- 2003: 1
- 2005: 1
- 2007: 1
- 2009: 2
- 2010: 2
- 2013: 1
- 2016: 1
- 2017: 1
- 2018: 1
- 2021: 1

## Most-cited predicates
- K051053: Oscar, Model OE3000DB (2005), cited by 3
- K100410: Piezoelectric System (2010), cited by 3
- K172464: XD880A Ultrasonic Osteotomy Surgical System (2018), cited by 2
- K153743: Piezosurgery Plus (2016), cited by 2
- K031280: Ultra-Drive 3 (2003), cited by 2
- K132848: Piezosurgery Flex (2013), cited by 2
- K083284: Piezosurgery Medical (2009), cited by 2
- K961725: Oscar Orthosonics System for Cemented Arthroplasty Revision (1996), cited by 2
- K900003: System Ten Model 100 Surgical System (1990), cited by 2
- K083830: Oscar Bone Resector (2009), cited by 1

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