FDA applicant
Osteomed LP
FDA records 73 decisions for Osteomed LP (Addison, TX) from 1991 to 2022: 73 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 92 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. Its devices cite 143 predicates, 50 of them its own earlier devices. 4 recalls are linked to its devices.
FDA’s records also spell it “Osteomed Corp.”, “Osteomed”, “Osteomed, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Osteomed LP’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
2in 2023
Class I Class II/III not classified
Planning a device like Osteomed LP’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 “Osteomed”
FDA records each applicant name separately; these may or may not be the same firm.