510(k) Report

Devices descending from K142661

15 later devices reach Bi-Portal Bone Graft Delivery Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233368Allograft Delivery Device (OFAC-C)Bioventus, LLC20240—
+1K231456Avitus® DragonWing Large Volume Autograft Delivery SystemAvitus Orthopaedics, Inc.20230—
+1K230492Avitus® Precision Autograft Delivery SystemAvitus Orthopaedics, Inc.20230—
+1K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC201711—
+2K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC20260—
+2K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC20251—
+2K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+2K210997PreferX Delivery SystemMd3, LLC20210—
+2K2004313D GraftRasp SystemSurgentec20201—
+2K200606O-Genesis Graft Delivery SystemOrthofix, Inc.20200—
+2K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC20186—
+3K2019003D GraftRasp SystemSurgentec20200—
+3K201338Allograft MIS Delivery SystemLifenet Health20202—
+4K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc.20241—
+5K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.20250—