FDA applicant
Aesculap Implant Systems, LLC
FDA records 51 decisions for Aesculap Implant Systems, LLC (Center Valley, PA) from 2007 to 2022: 51 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and JWH (Prosthesis, Knee, Patellofemorotibial…). Since 2016 its 510(k)s took a median of 159 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 175 predicates, 39 of them its own earlier devices. 14 recalls are linked to its devices.
FDA’s records also spell it “Aesculap Implant Systems, Inc.”, “Aesculap Implant Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Aesculap Implant Systems, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Aesculap Implant Systems, LLC’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 “Aesculap”
FDA records each applicant name separately; these may or may not be the same firm.