Cleared Traditional

K051246 - CONSTRUX MINI PEEK VBR SYSTEM

K051246 is an FDA 510(k) clearance for CONSTRUX MINI PEEK VBR SYSTEM, manufactured by Blackstone Medical, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K051246 · Blackstone Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jun 2005
Decision
29d
Days
Class 2
Risk

K051246 is an FDA 510(k) clearance for the CONSTRUX MINI PEEK VBR SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Springfield, US). The FDA issued a Cleared decision on June 14, 2005 after a review of 29 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 Blackstone Medical, Inc. devices

FDA 510(k) Submission Details - K051246

510(k) Number K051246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2005
Decision Date June 14, 2005
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 K051246.
OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)
K043349 · Ldr Spine USA · Jun 2005
STALIF TT
K051027 · Surgicraft , Ltd. · Jun 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
K051196 · Implex Corp. · Jun 2005
BASIS VERTEBRAL BODY SPACER
K051105 · Medtronic Sofamor Danek · Jun 2005
CO VERTEBRAL BODY REPLACEMENT
K050348 · Scient'X · May 2005
PEEK CAS
K050861 · Interpore Cross Intl. · May 2005