FDA applicant
Orthopaedic Biosystems, Ltd.
FDA records 14 decisions for Orthopaedic Biosystems, Ltd. (Scotsdale, AZ) from 1991 to 2000: 14 510(k) clearances. Most are in product codes JDR (Staple, Fixation, Bone) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Its devices cite 6 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Orthopaedic Biosystems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Orthopaedic Biosystems, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Orthopaedic Biosystems, Ltd. since 2007.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Orthopaedic Biosystems, 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