FDA applicant
Implantcast GmbH
FDA records 20 decisions for Implantcast GmbH (Buxtehude, DE) from 2017 to 2026: 20 510(k) clearances. Most are in product codes LZO (Prosthesis, Hip, Semi-Constrained…) and KWT (Prosthesis, Shoulder, Non-Constrained…). Since 2016 its 510(k)s took a median of 224 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 92 predicates, 42 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Implantcast GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Implantcast GmbH’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