510(k) Report

Devices descending from K190365

36 later devices reach Baby Gorilla/Gorilla Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221558ALPHALOK Plating SystemVilex, LLC20222—
+1K221395Footmotion Plating SystemNewclip Technics20220—
+1K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+1K203511Baby Gorilla/Gorilla Plating SystemParagon 28, Inc.202017—
+1K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+1K192592Axis Plating SystemExtremity Medical, LLC20190—
+2K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+2K250952Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.20252—
+2K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+2K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+2K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+2K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+2K230623KITE Distal Fibula KitIntrauma S.P.A20230—
+2K230204ALPHALOK Plating SystemVilex, LLC20230—
+2K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+2K221465Baby Gorilla/Gorilla Plating SystemParagon 28, Inc.20226—
+2K211843PolyLock Plating SystemFusion Orthopedics20220—
+2K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+2K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+3K260810Anteralign LS coverplateTyber Medical, LLC20260—
+3K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+3K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+3K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+3K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+3K222194Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.20225—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+4K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+5K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—