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510(k) K252596

Tigon Medical Knotless and Dual Javelin All-Suture Anchors by Tigon Medical — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2025
Date Received
August 15, 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 Tigon Medical

  • K242529 — Tigon Medical All-Suture Anchors (ASA) (December 20, 2024)
  • K240175 — Tigon Medical Fractures, Instability, and Reconstruction (FIRE) (October 29, 2024)
  • K220464 — Tigon Medical Gryphon Anchor Line (March 22, 2023)
  • K211049 — Tigon Medical Button System (August 4, 2021)
  • K182507 — Tigon Medical Tissue Anchors (January 21, 2019)

Other clearances for product code MBI

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  • K253693 — Strut Suture; No-Tie Button (March 11, 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)