# PBJ: Cranial Distraction System

- Device class: 2; regulation: 21 CFR 882.5330; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 299 days (middle half 299–299)
- 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)
- 2012: 1
- 2013: 1
- 2015: 1
- 2017: 2
- 2023: 1

## Most-cited predicates
- K170818: Craniomaxillofacial Distraction System (CMFD) (2017), cited by 1
- K121304: Osteomed Cranial Distraction System (2012), cited by 1
- K123885: Osteomed Smartflex Cranial Spring Distractor (2013), cited by 1

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