510(k) Report

Devices descending from K963402

18 later devices reach Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060970Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc.20061021
+1K982996Polymer Obl SB Anchor / Suture CombinationOrthopaedic Biosystems, Ltd.19990—
+1K983169Polymer Threaded AnchorOrthopaedic Biosystems, Ltd.19980—
+1K982963Polymer Threaded Anchor / Suture CombinationOrthopaedic Biosystems, Ltd.19984—
+2K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+2K102143Suspension Acromioclavicular (AC) Repair SystemSuspension Orthopaedic Solutions, LLC20100—
+2K083268Tornier, Inc., Insite Suture AnchorsTornier, Inc.20097—
+2K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc.20013—
+3K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+3K122635Tornier Insite FT Biocomposite Suture AnchorTornier, Inc.20130—
+3K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+3K061498Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation200601
+3K042038MTF Allograft AnchorMusculoskeletal Transplant Foundation20041—
+4K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+4K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+4K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+4K053339Allofix AnchorMusculoskeletal Transplant Foundation20060—
+5K253538TeKBrace Knotless AnchorTheramicro20260—