510(k) Report

Devices descending from K121250

18 later devices reach OP Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130655Response Spine SystemOrthoPediatrics Corp.201317—
+2K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+2K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+3K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—