510(k) Report

Devices descending from K052385

253 later devices reach Tangors Polyaxial System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+8K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+8K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+8K180376K2M Patient Specific RodsK2m, Inc.20182—
+8K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+10K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+10K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+10K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—