Cleared Special

K083810 - PASS LP SPINAL SYSTEM

K083810 is an FDA 510(k) clearance for PASS LP SPINAL SYSTEM, manufactured by Medicrea Technologies. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 221-day FDA review.

K083810 · Medicrea Technologies · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
221d
Days
Class 2
Risk

K083810 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 Technologies (Round Rock, US). The FDA issued a Cleared decision on July 31, 2009 after a review of 221 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 - K083810

510(k) Number K083810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date July 31, 2009
Days to Decision 221 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
99d slower than avg
Panel avg: 122d · This submission: 221d
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 K083810.
CASPIAN SPINAL SYSTEM
K092640 · K2m, Inc. · Nov 2009
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093170 · Spineart · Nov 2009
MODIFICATION TO: PSS SYSTEM
K092128 · Spinal USA · Sep 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K091189 · Alphatec Spine, Inc. · Jul 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K090779 · Alphatec Spine, Inc. · Jul 2009
INERTIA PEDICLE SCREW SYSTEM
K090984 · Nexxt Spine, LLC · Jun 2009
K083810 · PASS LP SPINAL SYSTEM
Download PDF FDA Summary Medicrea Technologies