510(k) Report

Devices descending from K121693

21 later devices reach A-Wedge Anterior Interbody System (a-Wedge Ais) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+1K132738Cogent Med-LifCogent Spine, LLC201413—
+1K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+2K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+2K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+2K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+2K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+2K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+3K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+3K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—