510(k) Report

Devices descending from K041393

14 later devices reach Fassier-Duval Telscopic IM System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241983Fassier-Duval Telescoping IM SystemOrthopediatrics Canada Ulc Dba Pega Medical20250—
+1K211292Fassier-Duval Telescopic IM SystemPega Medical, Inc.20212—
+1K160545Gap Endo-Exo Medullary SystemPega Medical, Inc.20166—
+1K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc.201561
+1K111232Gap Endo-Exo Medullary SystemPega Medical, Inc.201271
+2K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+2K232648RODEO Telescopic NailOrthofix Srl20240—
+2K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+2K192710The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc.20205—
+3K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+3K250197Estremo Fibular NailCitieffe S.R.L.20250—
+3K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+4K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—