510(k) Report

Devices descending from K170613

6 later devices reach Genius Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190577World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd.20195—
+2K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal…Signature Orthopaedics Pty, Ltd.20224—
+3K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+3K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+4K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+4K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—