510(k) Report

Devices descending from K993956

14 later devices reach Titanium Pediatric Femoral Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122823Sign Pediatric Fin NailSign Fracture Care International20130—
+1K111232Gap Endo-Exo Medullary SystemPega Medical, Inc.201271
+1K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp.2009627
+2K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc.201843
+2K172699Agile NailOrthofix Srl20180—
+2K160545Gap Endo-Exo Medullary SystemPega Medical, Inc.20166—
+3K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.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—