Cleared Traditional

K160640 - PASS XS Spinal System

K160640 is an FDA 510(k) clearance for PASS XS 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 200-day FDA review.

K160640 · Medicrea International SA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
200d
Days
Class 2
Risk

K160640 is an FDA 510(k) clearance for the PASS XS 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 September 23, 2016 after a review of 200 days - an extended review cycle.

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 - K160640

510(k) Number K160640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2016
Decision Date September 23, 2016
Days to Decision 200 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
78d slower than avg
Panel avg: 122d · This submission: 200d
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 K160640.
M.U.S.T. Pedicle Screw System
K162061 · Medacta International S.A. · Oct 2016
CD HORIZON® Spinal System
K162494 · Medtronic Sofamor Danek USA, Inc. · Oct 2016
NuVasive® Reline® System
K161014 · Nu Vasive, Incorporated · Sep 2016
SeaSpine® NewPort™ Spinal System
K161535 · SeaSpine Orthopedics Corporation · Sep 2016
PathLoc-L MIS Spinal System
K161766 · L & K Biomed Co., Ltd. · Aug 2016
Genesys Spine TiLock Cortical Spinal System
K161914 · Genesys Spine · Aug 2016