Cleared Special

K110183 - ARTHROCARE PARALLAX CONTOUR VERTEBRAL A...

K110183 is the FDA 510(k) clearance for ARTHROCARE PARALLAX CONTOUR VERTEBRAL A... by Arthrocare Corp.. It is a Class 2 Orthopedic device (product code NDN) cleared through the Special 510(k) pathway after a 26-day FDA review.

K110183 · Arthrocare Corp. · Orthopedic device
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Feb 2011
Decision
26d
Days
Class 2
Risk

K110183 is an FDA 510(k) clearance for the ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Arthrocare Corp. (Sunnyvale, US). The FDA issued a Cleared decision on February 16, 2011 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arthrocare Corp. devices

Submission Details

510(k) Number K110183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2011
Decision Date February 16, 2011
Days to Decision 26 days
Submission Type Special
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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 44
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K110183.
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