510(k) Report

Devices descending from K980854

16 later devices reach Retrograde Pediatric Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020885Fassire-Duval Telescopic IM SystemPega Medical, Inc.2003154
+2K241983Fassier-Duval Telescoping IM SystemOrthopediatrics Canada Ulc Dba Pega Medical20250—
+2K211292Fassier-Duval Telescopic IM SystemPega Medical, Inc.20212—
+2K160545Gap Endo-Exo Medullary SystemPega Medical, Inc.20166—
+2K111232Gap Endo-Exo Medullary SystemPega Medical, Inc.201271
+2K041393Fassier-Duval Telscopic IM SystemPega Medical, Inc.2004145
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K232648RODEO Telescopic NailOrthofix Srl20240—
+3K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+3K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc.201561
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+4K192710The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc.20205—
+5K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K250197Estremo Fibular NailCitieffe S.R.L.20250—