510(k) Report

Devices descending from K041911

237 later devices reach Synthes (Usa) LCP Curved Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+6K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+6K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+6K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+6K180500VariAx 2 SystemStryker GmbH201812—
+7K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+7K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+8K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+8K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+9K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+9K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+9K233919VariAx 2 Distal Radius SystemStryker GmbH20242—