Cleared Traditional

K061151 - PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)

K061151 is an FDA 510(k) clearance for PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER), manufactured by Pioneer Surgical Technology. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K061151 · Pioneer Surgical Technology · Orthopedic device
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Jul 2006
Decision
90d
Days
Class 2
Risk

K061151 is an FDA 510(k) clearance for the PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER). Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Pioneer Surgical Technology (Marquette, US). The FDA issued a Cleared decision on July 24, 2006 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Pioneer Surgical Technology devices

FDA 510(k) Submission Details - K061151

510(k) Number K061151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2006
Decision Date July 24, 2006
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
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 - MQP Spinal Vertebral Body Replacement Device

All 267
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K061151.
VERTE-STACK SPINAL SYSTEM
K062073 · Medtronic Sofamor Danek · Aug 2006
VERTE-STACK SPINAL SYSTEM
K061938 · Medtronic Sofamor Danek, Inc. · Aug 2006
AVS ASL PEEK SPACER SYSTEM
K061836 · Stryker Spine · Aug 2006
MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM
K061576 · Quantum Orthopedics, Inc. · Jul 2006
ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.
K060916 · Spinal Edge, LLC · Jun 2006
EBI ESL PEEK-OPTIMA SPINE SYSTEM
K061016 · Ebi, L.P. · Jun 2006