510(k) Report

Devices descending from K070843

19 later devices reach Synthes Adolescent Lateral Entry Femoral Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182—
+1K172699Agile NailOrthofix Srl20180—
+1K172157DePuy Synthes Femoral Recon Nail SystemSynthes (USA) Products, LLC20172—
+1K111232Gap Endo-Exo Medullary SystemPega Medical, Inc.201271
+1K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp.2009627
+2K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+2K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—
+2K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc.201843
+2K160545Gap Endo-Exo Medullary SystemPega Medical, Inc.20166—
+3K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+3K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+3K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+3K220679Pediatric Nailing Platform FemurOrthoPediatrics Corp.20222—
+3K190321Pediatric Nailing PlatformFemurOrthoPediatrics Corp.20190—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—