Cleared Traditional

K071743 - PILLAR PEDICLE SCREW SYSTEM

K071743 is an FDA 510(k) clearance for PILLAR PEDICLE SCREW SYSTEM, manufactured by The 4th Column, LLC. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K071743 · The 4th Column, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
9d
Days
Class 2
Risk

K071743 is an FDA 510(k) clearance for the PILLAR PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by The 4th Column, LLC (San Diego, US). The FDA issued a Cleared decision on July 6, 2007 after a review of 9 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 The 4th Column, LLC devices

FDA 510(k) Submission Details - K071743

510(k) Number K071743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2007
Decision Date July 06, 2007
Days to Decision 9 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
113d faster than avg
Panel avg: 122d · This submission: 9d
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 206
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K071743.
Optima ZS Transition Screw
K071880 · Zimmer Spine, Inc. · Oct 2007
PSS SYSTEM
K071438 · Spinal USA · Aug 2007
NUVASIVE OCT SYSTEM
K071435 · Nuvasive, Inc. · Aug 2007
SYNAPSE SYSTEM
K070573 · Synthes Spine Co.Lp · Jun 2007
ROC LUMBAR SYSTEM
K063668 · Alphatec Spine, Inc. · May 2007
RANGE SPINAL SYSTEM
K070229 · K2m, Inc. · May 2007