Cleared Traditional

K043206 - PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)

K043206 is an FDA 510(k) clearance for PIONEER VERTEBRAL BODY REPLACEMENT DEVI..., 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 63-day FDA review.

K043206 · Pioneer Surgical Technology · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
63d
Days
Class 2
Risk

K043206 is an FDA 510(k) clearance for the PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER 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 January 21, 2005 after a review of 63 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 - K043206

510(k) Number K043206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2004
Decision Date January 21, 2005
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 K043206.
ATALIA TITANIUM SURGICAL MESH
K041798 · Us Spinal Technologies, LLC · Feb 2005
RABEA SPINAL IMPLANT
K043316 · Signus Medizintechnik GmbH · Feb 2005
NUVASIVE COROENT SYSTEM
K043405 · Nuvasive, Inc. · Feb 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043566 · Medtronic Sofamor Danek · Jan 2005
TITANIUM MESH IMPLANT
K041407 · Interpore Cross Intl. · Dec 2004
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5
K042713 · Spine Next America Corporation · Dec 2004