Cleared Special

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) (K162453) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K162453 · Pan Medical , Ltd. · Orthopedic device
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Nov 2016
Decision
61d
Days
Class 2
Risk

K162453 is an FDA 510(k) clearance for the 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (.... 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 November 1, 2016 after a review of 61 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

Submission Details

510(k) Number K162453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2016
Decision Date November 01, 2016
Days to Decision 61 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
61d faster than avg
Panel avg: 122d · This submission: 61d
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 26
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K162453.
KYPHON HV-R Bone Cement
K180700 · Medtronic Sofamor Danek USA, Inc. · May 2018
Kyphon Xpede Bone Cement
K163032 · Medtronic, Inc. · Feb 2017
CONCORD Plus Radiopaque Bone Cement
K162618 · Globus Medical, Inc. · Jan 2017
Kyphon HV-R Bone Cement
K160983 · Medtronic, Inc. · Aug 2016
KYPH X HV-R BONE CEMENT
K093828 · Medtronic, Inc. · Aug 2010
VERTEFIX VERTEBROPLASTY PROCEDURE SET
K042691 · Cook, Inc. · Nov 2005