FDA applicant
Pioneer Surgical Technology
FDA records 77 decisions for Pioneer Surgical Technology (Marquette, MI) from 1993 to 2026: 77 510(k) clearances. Most are in product codes JDQ (Cerclage, Fixation) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 74 days from receipt to decision, against 74 for FDA’s reviews in the same codes and years. Its devices cite 168 predicates, 83 of them its own earlier devices. 10 recalls are linked to its devices.
FDA’s records also spell it “Pioneer Surgical Technology, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pioneer Surgical Technology’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Pioneer Surgical Technology’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 “Pioneer”
FDA records each applicant name separately; these may or may not be the same firm.