Cleared Traditional

K230976 - Arthrex Radiopaque FiberTape Cerclage sutures

K230976 is an FDA 510(k) clearance for Arthrex Radiopaque FiberTape Cerclage s..., manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K230976 · Arthrex, Inc. · Orthopedic device
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Aug 2023
Decision
141d
Days
Class 2
Risk

K230976 is an FDA 510(k) clearance for the Arthrex Radiopaque FiberTape Cerclage sutures. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on August 24, 2023 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrex, Inc. devices

FDA 510(k) Submission Details - K230976

510(k) Number K230976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2023
Decision Date August 24, 2023
Days to Decision 141 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 122d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDQ Cerclage, Fixation

All 108
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K230976.
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STRETTO™ Cable System
K231333 · Globus Medical, Inc. · Aug 2023
HS Fiber Cerclage
K220765 · Riverpoint Medical, LLC · Jul 2023
STERN FIX Sternal Stabilization System
K221795 · Neos Surgery S.L · Oct 2022