Home / 510(k) Clearances / K243344

510(k) K243344

Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures by Arthrex, Inc. — Product Code JDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2025
Date Received
October 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cerclage, Fixation
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type

Other clearances by Arthrex, Inc.

  • K260405 — FiberTape Button (March 9, 2026)
  • K252196 — Arthrex FibuLock Nail System (March 5, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254229 — Arthrex Nano FiberTak Suture Anchor (March 2, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
  • K252807 — Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates (January 12, 2026)
  • K253895 — Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm (December 30, 2025)
  • K253727 — Syndesmosis TightRope PRO (December 22, 2025)
  • K252314 — Arthrex SutureTak Suture Anchor (October 29, 2025)
  • K251994 — Arthrex Synergy Vision Imaging System (October 16, 2025)

Other clearances for product code JDQ

  • K243905 — Stitch Cerclage – Suture Tapes (August 14, 2025)
  • K232733 — Mbrace Cable (May 3, 2024)
  • K233949 — ACCORD Cable System (March 13, 2024)
  • K232986 — VariTrax Sternal CircumFixation System (January 30, 2024)
  • K230976 — Arthrex Radiopaque FiberTape Cerclage sutures (August 24, 2023)
  • K231333 — STRETTO™ Cable System (August 4, 2023)
  • K220765 — HS Fiber Cerclage (July 26, 2023)
  • K221795 — STERN FIX Sternal Stabilization System (October 19, 2022)
  • K211613 — Stern Fix Sternal Stabilization System (January 19, 2022)
  • K201497 — EVOS Cabling System (October 28, 2020)