510(k) Report

Devices descending from K110908

25 later devices reach Aptus Foot 3.5 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243469SignexOsteonic Co., Ltd.20250—
+1K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+1K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+2K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+3K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+3K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+4K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—