510(k) Report

Devices descending from K071586

121 later devices reach Bioraptor 2.3 PK Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+3K170877Parcus SLiK Fix ScrewParcus Medical20171—
+3K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+3K143392Quattro Bolt Tenodesis ScrewCayenne Medical, Inc.20150—
+3K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+3K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical201451
+3K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+3K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134—
+3K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+3K111471Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)Medshape Solutions, Inc.201111
+4K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+4K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+4K241577Iconix® AnchorRiverpoint Medical20240—
+4K233468Iconix AnchorRiverpoint Medical20231—
+4K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+4K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+4K192810Apollo Suture Anchor SystemValeris Medical20201—
+4K152255BoneCam Suture AnchorsValeris Medical20151—
+4K132783Exoshape Duo Soft Tissue FastenerMedShape, Inc.20130—
+5K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—
+5K193108Bonecam Suture AnchorValeris Medical, Inc.20200—