Cleared Traditional

SECURE-LOOP (K151601) - FDA 510(k) Clearance

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

K151601 · Xiros, Ltd. · Orthopedic device
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Sep 2015
Decision
89d
Days
Class 2
Risk

K151601 is an FDA 510(k) clearance for the SECURE-LOOP. 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 Xiros, Ltd. (Leeds, GB). The FDA issued a Cleared decision on September 9, 2015 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Xiros, Ltd. devices

Submission Details

510(k) Number K151601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2015
Decision Date September 09, 2015
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 322
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K151601.
Arthrex Short Suture Anchors
K151092 · Arthrex, Inc. · Feb 2016
Adjustable Fixation Device
K153186 · Arthrocare Corp. · Jan 2016
PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors
K152566 · Smith & Nephew, Inc. · Dec 2015
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K150648 · Arthrex, Inc. · Aug 2015
Arthrex Corkscrew and SwiveLock Suture Anchors
K143745 · Arthrex, Inc. · Jul 2015
Arthrex FiberTak Anchors
K151230 · Arthrex, Inc. · Jun 2015