Cleared Traditional

K090222 - PIONEER LUMBAR PLATE SYSTEM

K090222 is an FDA 510(k) clearance for PIONEER LUMBAR PLATE SYSTEM, manufactured by Pioneer Surgical Technology. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K090222 · Pioneer Surgical Technology · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
88d
Days
Class 2
Risk

K090222 is an FDA 510(k) clearance for the PIONEER LUMBAR PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Pioneer Surgical Technology (Marquette, US). The FDA issued a Cleared decision on April 28, 2009 after a review of 88 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 devices

FDA 510(k) Submission Details - K090222

510(k) Number K090222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2009
Decision Date April 28, 2009
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

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 612
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K090222.
SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM
K091044 · Spinal USA · Jul 2009
THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS
K091253 · K2m, Inc. · Jun 2009
NUVASIVE LATERAL PLATE SYSTEM
K091071 · Nuvasive, Inc. · May 2009
MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM
K090316 · Lanx, Inc. · Apr 2009
BLACK WIDOW ANTERIOR BUTTRESS PLATE
K081770 · Omni Surgical, L.P. · Apr 2009
STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM
K083020 · Stryker Corp. · Mar 2009