Cleared Traditional

K051820 - PARALLAX EZFLOW CEMENT DELIVERY SYSTEM (FDA 510(k) Clearance)

Class I Orthopedic device.

K051820 · Arthrocare Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 2005
Decision
63d
Days
Class 1
Risk

K051820 is an FDA 510(k) clearance for the PARALLAX EZFLOW CEMENT DELIVERY SYSTEM. Classified as Injector, Vertebroplasty (does Not Contain Cement) (product code OAR), Class I - General Controls.

Submitted by Arthrocare Corp. (Sunnyvale, US). The FDA issued a Cleared decision on September 6, 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 888.4200 - 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 Arthrocare Corp. devices

Submission Details

510(k) Number K051820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2005
Decision Date September 06, 2005
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OAR Injector, Vertebroplasty (does Not Contain Cement)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4200
Definition Intended For Injection Of Vertebroplasty Bone Cement For The Fixation Of Pathological Fractures Of The Vertebral Body Using Vertebroplasty Or Kyphoplasty Procedures. Painful Vertebral Compression Fractures May Result From Osteoporosis, Benign Lesions (hemangioma), And Malignant Lesions (metastatic Cancers, Myeloma).
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.