Cleared Traditional

K100297 - PASS LP SPINAL SYSTEM

K100297 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 Traditional 510(k) pathway after a 30-day FDA review.

K100297 · Medicrea Technologies · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
30d
Days
Class 2
Risk

K100297 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 March 4, 2010 after a review of 30 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medicrea Technologies devices

FDA 510(k) Submission Details - K100297

510(k) Number K100297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2010
Decision Date March 04, 2010
Days to Decision 30 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 199
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K100297.
AEGIS & AEGIS II SPINAL SYSTEM
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ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100138 · Alphatec Spine, Inc. · Feb 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K093077 · Alphatec Spine, Inc. · Dec 2009
KRD1 PEDICLE SCREW SYSTEM
K092420 · Spinefrontier, Inc. · Nov 2009