Cleared Special

K110497 - PASS LP SPINAL SYSTEM

K110497 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 MNH cleared through the Special 510(k) pathway after a 216-day FDA review.

K110497 · Medicrea International · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
216d
Days
Class 2
Risk

K110497 is an FDA 510(k) clearance for the PASS LP SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Medicrea International (Round Rock, US). The FDA issued a Cleared decision on September 26, 2011 after a review of 216 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. 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. Standard predicate reliance. 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 - K110497

510(k) Number K110497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2011
Decision Date September 26, 2011
Days to Decision 216 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 122d · This submission: 216d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 303
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K110497.
LANCER PEDICLE SCREW SYSTEM
K110633 · Spinal Solutions, LLC · Dec 2011
XINGTM SPINE SYSTEM
K111995 · Implanova Co., Ltd. · Dec 2011
DEVINE SPINAL SYSTEM
K111690 · Changzhou Orthmed Medical Instrument Co., Ltd. · Nov 2011
ODALYS PEDICLE SCREW SYSTEM
K111370 · Kalitec Direct, LLC · Sep 2011
REXIOUS SPINAL FIXATION SYSTEM
K111362 · Dio Medical Co., Ltd. · Jul 2011
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K102458 · Solco Biomedical Co., Ltd. · Jun 2011