Cleared Traditional

K153413 - PASS LP Spinal System

K153413 is an FDA 510(k) clearance for PASS LP Spinal System, manufactured by Medicrea International SA. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K153413 · Medicrea International SA · Orthopedic device
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Apr 2016
Decision
149d
Days
Class 2
Risk

K153413 is an FDA 510(k) clearance for the PASS LP Spinal System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Medicrea International SA (Neyron, FR). The FDA issued a Cleared decision on April 22, 2016 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Medicrea International SA devices

FDA 510(k) Submission Details - K153413

510(k) Number K153413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2015
Decision Date April 22, 2016
Days to Decision 149 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
27d slower than avg
Panel avg: 122d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 706
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K153413.
NuVasive® Reline® System
K160989 · Nu Vasive, Incorporated · Jun 2016
Mariner Pedicle Screw System
K160902 · SeaSpine Orthopedics Corporation · May 2016
Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
K160980 · Spineology, Inc. · May 2016
Diplomat® Spinal System
K151704 · Signus Medizintechnik GmbH · Apr 2016
Response 5.5 Spine System
K160466 · OrthoPediatrics Corp. · Mar 2016
Palisade Pedicular Fixation System
K153323 · Spineology, Inc. · Feb 2016