Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures— 510(k) K243344

Name: FDA 510(k) clearance K243344
Creator: U.S. Food and Drug Administration
Published: 2025-02-20

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K243344 for Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures, Substantially Equivalent on 2025-02-20. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code JDQ
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2024-10-25
Decision date: 2025-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDQ

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K261271 — Cable-Ready® Cable Grip System2026-07-16
K243905 — Stitch Cerclage Suture Tapes2025-08-14
K232733 — Mbrace Cable2024-05-03
K233949 — ACCORD Cable System2024-03-13
K232986 — VariTrax Sternal CircumFixation System2024-01-30

More clearances from Arthrex, Inc.

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K262451 — Arthrex DynaNite Staples2026-09-01
K262357 — Arthrex Bioabsorbable PushLock Suture Anchors2026-08-07
K260624 — Arthrex Radial Head Replacement System2026-07-30
K260018 — Arthrex FiberButton2026-06-26
K260809 — Arthrex Sterile VAL and VAL KreuLock Compression Screw System2026-06-25

Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.