510(k) Report

Devices descending from K000636

49 later devices reach Stryker Trauma Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132502Variax 2 SystemStryker Trauma AG201321—
+1K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+1K072411Aap Bone Plates and Screw ImplantsAap Implantate AG20089—
+1K040908Ebi Distal Radius Plating SystemEbi, L.P.20044—
+2K223772PRO Plating System, Stryker Trauma Pelvic Set (Matta)Stryker GmbH20231—
+2K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+2K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+2K182818LOQTEQ VA Calcaneus Plate 3.5Aap Implantate AG20190—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K173556Injection ScrewBiedermann Medtech, Inc.20180—
+2K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K161703LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, WasherAap Implantate AG20160—
+2K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+2K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+2K150974aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, TitaniumAap Implantate AG20150—
+2K141949Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping…Aap Implantate AG20140—
+2K140769Variax 2 SystemStryker Trauma AG201419—
+2K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+2K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+2K110271Maestro Wrist Plating SystemBiomet Manufacturing Corp20110—
+2K093761Optilock VL (Variable Angle Locking) Distal Radius Plating SystemBiomet Trauma (Aka Ebi, Lp)20103—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K173135VariAx 2 SystemStryker GmbH201713—
+3K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+3K150675Dorsal Spanning PlateSkeletal Dynamics, LLC20151—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+4K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+4K180500VariAx 2 SystemStryker GmbH201812—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+5K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+6K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+7K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+7K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+7K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+7K233919VariAx 2 Distal Radius SystemStryker GmbH20242—