Cleared Traditional

K223284 - SutureLoc™ Implant

K223284 is an FDA 510(k) clearance for SutureLoc Implant, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K223284 · Arthrex, Inc. · Orthopedic device
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Feb 2023
Decision
100d
Days
Class 2
Risk

K223284 is an FDA 510(k) clearance for the SutureLoc™ Implant. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on February 2, 2023 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 - K223284

510(k) Number K223284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2022
Decision Date February 02, 2023
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 565
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K223284.
OrthoButton AL
K230212 · Riverpoint Medical, LLC · Feb 2023
ULTRABUTTON QUAD Adjustable Fixation Device
K222971 · Smith & Nephew, Inc. · Feb 2023
Simparo Anchor Line Fixation System
K222574 · Simparo, Inc. · Feb 2023
Flexible Suturing System with Anchors (FSSA)
K222589 · Integrity Orthopaedics, Inc. · Jan 2023
FairFix QT Adjustable Button
K223795 · Medacta International S.A. · Jan 2023
Arthrex FiberTak Suture Anchor
K221396 · Arthrex, Inc. · Dec 2022