510(k) Report

Devices descending from K101557

10 later devices reach Gamma-BSM, Beta-BSM, Equivabone, Carigen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+1K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+1K182107CarriGen PFEtex Corporation20181—
+1K102528N-Force Fixation SystemInnovision, Inc.20115—
+1K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+2K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+2K151146N-Force Fixation SystemInnovision, Inc.20151—
+2K142776Flow-ScrewFlow-Fx, LLC20151—
+2K132244N-Force Fixation SystemInnovision, Inc.20143—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—