# Promethean Restorative, LLC

- Location (FDA's records): Castle Rock, CO
- FDA decisions: 3 (2025–2026): 3 510(k) clearances
- Product codes: OUR (2), OLO (1)
- 510(k) review time since 2016: median 102 days, against 97 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- SI-BONE, Inc.: 1 (https://510kreport.com/company/si-bone)
- Curiteva, Inc.: 1 (https://510kreport.com/company/curiteva)
- Genesys Spine: 1 (https://510kreport.com/company/genesys-spine)
- Precision Spine, Inc.: 1 (https://510kreport.com/company/precision-spine)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Innovasis, Inc.: 1 (https://510kreport.com/company/innovasis)

## Its most-cited devices
- K243565: DYNAMIS™ SI Screw System (2025), cited by 1

## Recent decisions
- K252962: DYNAMIS™ Navigation System (Jan 12, 2026)
- K251075: DYNAMIS™ Implant System (Apr 25, 2025)
- K243565: DYNAMIS™ SI Screw System (Feb 28, 2025)

Source page: https://510kreport.com/company/promethean-restorative