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510(k) K253693

Strut Suture; No-Tie Button by Riverpoint Medical, LLC — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2026
Date Received
November 21, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Riverpoint Medical, LLC

  • K253695 — LigaMend (February 27, 2026)
  • K253024 — ProZip Knotless Implant (October 16, 2025)
  • K252201 — HS Fiber (August 13, 2025)
  • K252144 — Iconix Speed Anchor; Iconix Speed HA+ Anchor (July 30, 2025)
  • K243988 — RootMend MRR (March 20, 2025)
  • K242494 — OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct (November 26, 2024)
  • K243323 — Iconix Knotless Anchor (November 19, 2024)
  • K243203 — OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor (October 29, 2024)
  • K241282 — RibFix Titan™ Fixation System (August 19, 2024)
  • K241577 — Iconix® Anchor (July 3, 2024)

Other clearances for product code MBI

  • K251750 — Trax EX Anchor (March 12, 2026)
  • K260405 — FiberTape Button (March 9, 2026)
  • K253538 — TeKBrace Knotless Anchor (March 6, 2026)
  • K254306 — Aevumed FENIX Suture Anchor (March 4, 2026)
  • K254229 — Arthrex Nano FiberTak Suture Anchor (March 2, 2026)
  • K253695 — LigaMend (February 27, 2026)
  • K253763 — Y-Knotless™ Flex Anchors (January 29, 2026)
  • K260004 — Aevumed PROTEKT Suture Anchor (January 28, 2026)
  • K253618 — QuadLock™ Fixation System (January 6, 2026)
  • K253895 — Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm (December 30, 2025)