Cleared Traditional

K131427 - LOTUS

K131427 is the FDA 510(k) clearance for LOTUS by Spinal Elements, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K131427 · Spinal Elements, Inc. · Orthopedic device
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Oct 2013
Decision
160d
Days
Class 2
Risk

K131427 is an FDA 510(k) clearance for the LOTUS. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 24, 2013 after a review of 160 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Spinal Elements, Inc. devices

Submission Details

510(k) Number K131427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2013
Decision Date October 24, 2013
Days to Decision 160 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
38d slower than avg
Panel avg: 122d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 272
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K131427.
SYNAPSE SYSTEM
K133698 · Synthes USA Products, LLC · Jan 2014
CERTEX OCT SPINAL IMPLANT SYSTEM
K133094 · X-Spine Systems, Inc. · Dec 2013
TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
K132504 · Corelink, LLC · Nov 2013
MOUNTAINEER OCT SPINAL SYSTEM
K132332 · Medos International SARL · Aug 2013
VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
K123906 · Medtronic Sofamor Danek USA, Inc. · Apr 2013
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS
K123783 · Globus Medical, Inc. · Mar 2013