FDA applicant
Trilliant Surgical, Ltd.
FDA records 18 decisions for Trilliant Surgical, Ltd. (Houston, TX) from 2007 to 2022: 18 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 119 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. Its devices cite 49 predicates, 20 of them its own earlier devices. 19 recalls are linked to its devices.
FDA’s records also spell it “Trilliant Surgical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Trilliant Surgical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Trilliant Surgical, Ltd.’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) Report