FDA applicant
Promethean Restorative, LLC
FDA records 3 decisions for Promethean Restorative, LLC (Castle Rock, CO) from 2025 to 2026: 3 510(k) clearances. Most are in product codes OUR (Sacroiliac Joint Fixation) and OLO (Orthopedic Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 102 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Promethean Restorative, LLC’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Promethean Restorative, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Promethean”
FDA records each applicant name separately; these may or may not be the same firm.