510(k) Report

Devices descending from K033272

351 later devices reach Depuy Sigma Tibial Inserts through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+8K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+8K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+8K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+8K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+8K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+8K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+8K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+8K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+8K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+8K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+8K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+8K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+8K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+8K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+8K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+8K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+8K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+9K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+9K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+9K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+9K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+9K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+9K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+9K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+9K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+9K210153NextAR RSA PlatformMedacta International S.A.202151
+9K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+9K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+10K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+10K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+10K252847NextAR Hip PlatformMedacta International S.A.20260—
+10K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+10K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+10K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+10K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+10K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+10K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+10K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+10K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+10K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+10K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+10K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+10K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+11K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+11K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+11K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+11K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+11K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+12K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—