FDA applicant
Signature Orthopaedics Pty, Ltd.
FDA records 45 decisions for Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU) from 2012 to 2026: 45 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and MEH (Prosthesis, Hip, Semi-Constrained, Uncemented…). Since 2016 its 510(k)s took a median of 186 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 153 predicates, 51 of them its own earlier devices. 5 recalls are linked to its devices.
FDA’s records also spell it “Signature Orthopaedics Pty Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Signature Orthopaedics Pty, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
7in 2025
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Signature Orthopaedics Pty, 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 “Signature”
FDA records each applicant name separately; these may or may not be the same firm.