510(k) Report

Devices descending from K945109

36 later devices reach Monoject Bone Marrow Biopsy Trays through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961959MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc.199635—
+2K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc.199834Class I
+3K180807Celling Aspiration NeedleSpine Smith Holdings, LLC20180—
+3K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH20171—
+3K062833Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation200614—
+3K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Sterylab S.R.L.200518—
+3K043523Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc.200514—
+4K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical20250—
+4K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.201312—
+4K072045Oncontrol Bone Marrow Biopsy SystemVidacare Corporation20077—
+4K071732MarrowminerStemcor Systems, Inc.20074—
+4K070759Powered EZ-IO Pediatric Bone Marrow Aspiration SystemVidacare Corporation20073—
+4K070179Trokabone, Trokabone SternalPAJUNK GmbH Medizintechnologie20070—
+4K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+5K260572Marrow MarxmanMedimetrix, LLC20260—
+5K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+5K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+5K213213Arthrex Vortex Threaded Bone Marrow Recovery NeedleArthrex, Inc.20210—
+5K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Ranfac Corporation20190—
+5K183146Ranfac Cartilage Biopsy NeedleRanfac Corporation20190—
+5K152474Avitus Bone HarvesterAvitus Orthopaedics, Inc.201531
+5K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.20154—
+5K141910Intraosseous Cannula System Bio-MAC¿ and Bio-COREBiologic Therapies, Inc.201502
+5K142377The OnControl Bone Marrow Biopsy System by VidacareVidacare, LLC201424
+5K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.20145—
+5K081713Vertebral Access System by VidacareVidacare Corporation20084—
+6K230015OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power…Laurane Medical Sas20230—
+6K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation20231—
+6K213896BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular20220—
+6K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…Biopsybell S.R.L.20210—
+6K202287Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation20201—
+6K170539Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone…Avitus Orthopaedics, Inc.201721
+6K112468The Oncontrol Bone Access System by VidacareRegulatory Specialists, Inc.20113—
+7K210631Avitus (r) Bone HarvesterAvitus Orthopaedics, Inc.20211—
+7K113872The Oncontrol Bone Access and Bone Biopsy System by VidacareVidacare Corporation201222
+8K243407Forcyte Autograft Harvest KitForcyte Medical, LLC20250—