Cleared Traditional

K221128 - Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II

K221128 is an FDA 510(k) clearance for Arthrex ACL TightRope, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K221128 · Arthrex, Inc. · Orthopedic device
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Oct 2022
Decision
170d
Days
Class 2
Risk

K221128 is an FDA 510(k) clearance for the Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on October 5, 2022 after a review of 170 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 - K221128

510(k) Number K221128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2022
Decision Date October 05, 2022
Days to Decision 170 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
48d slower than avg
Panel avg: 122d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAI Device Classification - Class 2, Special Controls

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 209
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K221128.
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Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL
K220833 · Acuitive Technologies, Inc. · Nov 2022
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K221099 · Arthrex, Inc. · May 2022
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K213958 · Embody, Inc. · Apr 2022