510(k) Report

Devices descending from K970119

5 later devices reach Mitek Absorbable Polydioxanone (PDS) H Fix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023388Mitek Rapidloc-PDS Meniscal Repair SystemMitek Worldwide20022—
+1K002406Mitek 2GII Meniscal Repair SystemMitek Products20014—
+2K092836Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2 Meniscal Repair…Depuy Mitek, A Johnson & Johnson Company20100—
+2K082518Dual Needle Suture Passer SystemCayenne Medical, Inc.20090—
+2K053492BioductBioduct, LLC20070—