Cleared Traditional

K132620 - INTER V KYPHOPLASTY CATHETER (BALLOON L...

K132620 is an FDA 510(k) clearance for INTER V KYPHOPLASTY CATHETER (BALLOON L..., manufactured by Pan Medical , Ltd.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K132620 · Pan Medical , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
238d
Days
Class 2
Risk

K132620 is an FDA 510(k) clearance for the INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHE.... Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Pan Medical , Ltd. (Gloucester, Gloucestershire, GB). The FDA issued a Cleared decision on April 16, 2014 after a review of 238 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Pan Medical , Ltd. devices

FDA 510(k) Submission Details - K132620

510(k) Number K132620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2013
Decision Date April 16, 2014
Days to Decision 238 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
116d slower than avg
Panel avg: 122d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K132620.
Kyphon HV-R Bone Cement
K160983 · Medtronic, Inc. · Aug 2016
KYPHON XPEDE Bone Cement
K151227 · Medtronic · Nov 2015
Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
K150582 · Stryker Corporation · Jun 2015
STRYKER IVAS BALLOON CATHETER
K123942 · Stryker Corporation · Apr 2013
IVAS BALLOON CATHETER
K113154 · Stryker Corporation · Jan 2012
CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G
K112907 · Medos International SARL · Dec 2011