FDA applicant
Intermedics Orthopedics
FDA records 108 decisions for Intermedics Orthopedics (Austin, TX) from 1982 to 1997: 108 510(k) clearances. Most are in product codes JDI (Prosthesis, Hip, Semi-Constrained…) and JWH (Prosthesis, Knee, Patellofemorotibial…). Its devices cite 14 predicates, 8 of them its own earlier devices. 14 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Intermedics Orthopedics’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Intermedics Orthopedics since 2007.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Intermedics Orthopedics’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 “Intermedics”
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