510(k) Report

Devices descending from K150867

3 later devices reach Affixus Tibial Nailing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+2K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+3K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—