510(k) Report

Devices descending from K961497

628 later devices reach Profyle Titanium Hand and Small Fragment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+8K211843PolyLock Plating SystemFusion Orthopedics20220—
+8K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+8K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+8K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+8K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+8K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+8K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+8K191009Arsenal Plating SystemTrilliant Surgical20192—
+8K181091AxSOS 3 TiStryker GmbH201811—
+8K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+8K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+8K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+9K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+9K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+9K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+9K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+9K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+9K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+9K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+9K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+9K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+9K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+10K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+10K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+10K143092Tensyn PlugDallen Medical, Inc.20151—
+11K150359Tensyn PlugDallen Medical, Inc.20150—