Cleared Special

K150322 - InterV Kyphoplasty Catheter (Balloon Le...

K150322 is an FDA 510(k) clearance for InterV Kyphoplasty Catheter (Balloon Le..., manufactured by Pan Medical , Ltd.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Special 510(k) pathway after a 25-day FDA review.

K150322 · Pan Medical , Ltd. · Orthopedic device
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Mar 2015
Decision
25d
Days
Class 2
Risk

K150322 is an FDA 510(k) clearance for the InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplas.... Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Pan Medical , Ltd. (Gloucester, GB). The FDA issued a Cleared decision on March 6, 2015 after a review of 25 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 Pan Medical , Ltd. devices

FDA 510(k) Submission Details - K150322

510(k) Number K150322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2015
Decision Date March 06, 2015
Days to Decision 25 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

NDN Device Classification - Class 2, Special Controls

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 53
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K150322.
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