Signature Orthopaedics Pty, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
44
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadMarch 12, 2026
K253239Active-V Total Knee System; World Total Knee SystemDecember 23, 2025
K251771Cambridge Partial KneeDecember 16, 2025
K243021Longboard Revision Hip StemAugust 7, 2025
K242674Freedom Posterior Cervical ScrewsMay 13, 2025
K242477Shoulder Soft Tissue AnchorsMay 12, 2025
K243043Origin™ Cemented Hip StemMay 2, 2025
K243029Origin™ TT StemMarch 11, 2025
K243162World LinerNovember 25, 2024
K240683Rx Knee SystemSeptember 11, 2024
K241690Logical Liner; World Liner; World Knee PatellaAugust 1, 2024
K231134VerteLoc Spinal SystemFebruary 13, 2024
K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewMay 3, 2023
K220495SignaSure Dual Mobility SystemJanuary 13, 2023
K223062World Total Knee SystemNovember 4, 2022
K222380TriVerse Total Knee Replacement SystemOctober 4, 2022
K212870TLC Unicompartmental Knee SystemJune 16, 2022
K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS April 11, 2022
K211742SignaSure Dual Mobility SystemJanuary 7, 2022
K211505Encore Hip StemSeptember 24, 2021