Cleared Traditional

K120724 - PIONEER LATERAL PLATE SYSTEM

K120724 is the FDA 510(k) clearance for PIONEER LATERAL PLATE SYSTEM by Pioneer Surgical Technology, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K120724 · Pioneer Surgical Technology, Inc. · Orthopedic device
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May 2012
Decision
59d
Days
Class 2
Risk

K120724 is an FDA 510(k) clearance for the PIONEER LATERAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on May 7, 2012 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Pioneer Surgical Technology, Inc. devices

Submission Details

510(k) Number K120724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2012
Decision Date May 07, 2012
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 439
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K120724.
ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)
K121658 · Orthofix, Inc. · Jul 2012
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K121837 · Nuvasive, Inc. · Jul 2012
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K121049 · Globus Medical, Inc. · Jun 2012
PLYMOUTH THORACOLUMBAR PLATE SYSTEM
K120092 · Globus Medical, Inc. · Apr 2012
LEXUS ANTERIOR CERVICAL PLATE SYSTEM
K113509 · L & K Biomed Co., Ltd. · Jan 2012
K2M, PYRENEES CERVICAL PLATE SYSTEM
K113329 · K2m, Inc. · Jan 2012