Cleared Traditional

Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants (K221468) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221468 · Acuitive Technologies, Inc. · Orthopedic device
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Feb 2023
Decision
270d
Days
Class 2
Risk

K221468 is an FDA 510(k) clearance for the Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device,.... Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Acuitive Technologies, Inc. (Alendale, US). The FDA issued a Cleared decision on February 14, 2023 after a review of 270 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 Acuitive Technologies, Inc. devices

Submission Details

510(k) Number K221468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2022
Decision Date February 14, 2023
Days to Decision 270 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 122d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 122
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K221468.
Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)
K231326 · Osteonic Co., Ltd. · May 2023
EUROSCREW NG
K230394 · Teknimed · May 2023
Arthrex 3.9 mm SwiveLock Anchor
K230435 · Arthrex, Inc. · Mar 2023
Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL
K220833 · Acuitive Technologies, Inc. · Nov 2022
Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II
K221128 · Arthrex, Inc. · Oct 2022
Arthrex Self Punching SwiveLock Suture Anchors
K222263 · Arthrex, Inc. · Aug 2022