Cleared Special

K150049 - PASS LP Spinal System

K150049 is an FDA 510(k) clearance for PASS LP Spinal System, manufactured by Medicrea International. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 29-day FDA review.

K150049 · Medicrea International · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
29d
Days
Class 2
Risk

K150049 is an FDA 510(k) clearance for the PASS LP Spinal System. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Medicrea International (Neyron, FR). The FDA issued a Cleared decision on February 10, 2015 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K150049

510(k) Number K150049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2015
Decision Date February 10, 2015
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K150049.
Sniper Spine System
K151813 · Spine Wave, Inc. · Jul 2015
DPZ Pedicular Fixation System
K150294 · Osteomed Implantes, Ltda · Jun 2015
Polyscrew Pedicle Screw System
K150647 · New Era Orthopedics, LLC · Apr 2015
NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
K141253 · New Era Orthopaedics, LLC · Jan 2015
PASS LP SPINAL SYSTEM
K140738 · Medicrea International · Nov 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS
K141835 · Spineart · Sep 2014