510(k) Report

Devices descending from K203511

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250952Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.20252—
+1K230623KITE Distal Fibula KitIntrauma S.P.A20230—
+1K221465Baby Gorilla/Gorilla Plating SystemParagon 28, Inc.20226—
+1K211843PolyLock Plating SystemFusion Orthopedics20220—
+1K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+1K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+2K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+2K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+2K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+2K222194Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.20225—
+3K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+3K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+3K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—