510(k) Report

Devices descending from K000764

13 later devices reach Pediatric Fixation Rods through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193533WIN Flexible Nail SystemBiomet, Inc.20200—
+1K082375Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp.200810—
+1K0225312MM Pediatric Flex NailBiomet, Inc.20021—
+2K201838PediFlex Flexible Nail SystemOrthoPediatrics Corp.20211—
+2K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAILOrthofix Srl20170—
+2K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc.201561
+3K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.20250—
+3K192710The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc.20205—
+4K250197Estremo Fibular NailCitieffe S.R.L.20250—
+4K241983Fassier-Duval Telescoping IM SystemOrthopediatrics Canada Ulc Dba Pega Medical20250—
+4K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+5K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+6K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—