510(k) Report

Devices descending from K961608

577 later devices reach Synthes (U.S.a.) Polypin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+9K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+9K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+9K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+9K173135VariAx 2 SystemStryker GmbH201713—
+9K172921Stryker Self-Punching ICONIXStryker20170—
+9K171060OrthoButton ALRiverpoint Medical20178—
+9K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+9K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+10K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+10K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+10K253538TeKBrace Knotless AnchorTheramicro20260—
+10K253695LigaMendRiverpoint Medical, LLC20260—
+10K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+10K243988RootMend MRRRiverpoint Medical, LLC20250—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+10K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+10K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K241846E3D™-C Interbody SystemEvolution Spine20246—
+10K241912BiochargeNanofiber Solutions, LLC20240—
+10K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K240194ProCinch, QuadCinchRiverpoint Medical20240—
+10K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+10K233552IDEAL ZiploopRiverpoint Medical20230—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+10K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+10K230212OrthoButton ALRiverpoint Medical, LLC20232—
+10K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+10K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+10K202399OrthoButton FLRiverpoint Medical20201—
+10K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+10K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+10K180500VariAx 2 SystemStryker GmbH201812—
+11K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+11K262094E3D™-C Interbody SystemEvolution Spine20260—
+11K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+11K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+11K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+11K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+11K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+11K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+11K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+11K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+11K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+11K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+11K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+11K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+11K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+11K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+12K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+12K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+12K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+12K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+12K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+13K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+13K233919VariAx 2 Distal Radius SystemStryker GmbH20242—