FDA applicant
Stanmore Implants Worldwide, Ltd.
FDA records 8 decisions for Stanmore Implants Worldwide, Ltd. (Canton, MA) from 2011 to 2015: 8 510(k) clearances. Most are in product codes KRO (Prosthesis, Knee, Femorotibial, Constrained…) and JDI (Prosthesis, Hip, Semi-Constrained…). Its devices cite 26 predicates, 11 of them its own earlier devices. 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Stanmore Implants Worldwide, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Stanmore Implants Worldwide, 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) ReportOther applicant names beginning “Stanmore”
FDA records each applicant name separately; these may or may not be the same firm.