# OBT: Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 273 days (middle half 273–273)
- 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)
- 2010: 1
- 2011: 1
- 2018: 2
- 2019: 1
- 2022: 1

## Most-cited predicates
- K093442: Guided Growth System (2010), cited by 3
- K110805: Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel) (2011), cited by 1
- K172183: Guided Growth Plate System Plus (2018), cited by 1

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