510(k) Report

Devices descending from K153453

17 later devices reach Inertia Pedicle Screw and Deformity Correxxion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+1K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+1K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+1K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—