510(k) Report

Devices descending from K160545

6 later devices reach Gap Endo-Exo Medullary System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+1K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+2K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+2K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+3K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+3K261481Pangea Femur Reconstruction SystemStryker GmbH20260—