510(k) Report

Devices descending from K061362

126 later devices reach Pigalileo Total Knee Replacement (TKR) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+8K201149CoLink Plating SystemIn2bones USA, LLC20200—
+8K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+8K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+8K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+9K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+9K252246Leforte MMF SystemJeil Medical Corporation20260—
+9K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+9K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+9K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+9K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+9K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+9K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+9K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+9K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+9K192592Axis Plating SystemExtremity Medical, LLC20190—
+9K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+10K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+10K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+10K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+10K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+11K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+11K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+11K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+12K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+13K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—