510(k) Report

Devices descending from K040980

30 later devices reach Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252085Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)Wright Medical Technology, Inc. (Stryker Corporation)20250—
+1K061880Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV20075—
+1K050690ConnexusIsotis Orthobiologics, Inc.20056—
+1K040419Dynagraft IIIsotis Orthobiologics, Inc.200528—
+2K113728Surfuse Gel and Putty, Exfuse Gel and PuttyHans Biomed Corp.20124—
+2K103742Accell EVO3 (Formerly Accell A2I)Integra Life Sciences20110—
+2K091193Accell EVO3CIsotis Orthobiologics, Inc.200921
+2K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+2K071849Allofuse Gel and PuttyAllosource, Inc.200811
+2K081817Accell TBM-RIsotis Orthobiologics, Inc.20080—
+2K072265Progenix DMB PuttyMedtronic Sofamor Danek20084—
+2K070751Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyIsotis Orthobiologics, Inc.20071—
+2K050642Orthoblast II Putty and PasteIsotis Orthobiologics, Inc.20058—
+2K052098Connexus, .5CC, Model 023000-005Isotis Orthobiologics, Inc.20050—
+3K212135Dry DBM- A PuttySeaspine Corporation20211—
+3K171568SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse PuttyHans Biomed Corporation20180—
+3K152077MaxiGenHans Biomed Corp.20160—
+3K151271BellaFuseHans Biomed Corp.20160—
+3K130235Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp.20140—
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+3K103036Allofuse PlusAllosource, Inc.20110—
+3K082002Progenix PlusMedtronic Sofamor Danek20080—
+3K080462Progenix DBM PuttyMedtronic Sofamor Danek20082—
+3K061668Optecure +CCCExactech, Inc.20062—
+4K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+4K213260CMFlexTMDimension Inx Corp.20220—
+4K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc.20121—
+4K082463ProgenixMedtronic Sofamor Danek20080—
+4K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+5K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.20250—