Cleared Traditional

K150460 - KYPHON HV-R Bone Cement

K150460 is the FDA 510(k) clearance for KYPHON HV-R Bone Cement by Medtronic Sofamor Danck USA, Inc.. It is a Class 2 Orthopedic device (product code NDN) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K150460 · Medtronic Sofamor Danck USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
64d
Days
Class 2
Risk

K150460 is an FDA 510(k) clearance for the KYPHON (R) HV-R(R) Bone Cement. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Medtronic Sofamor Danck USA, Inc. (Memphis, US). The FDA issued a Cleared decision on April 28, 2015 after a review of 64 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. 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 Medtronic Sofamor Danck USA, Inc. devices

Submission Details

510(k) Number K150460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2015
Decision Date April 28, 2015
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 45
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K150460.
CONCORD Plus Radiopaque Bone Cement
K162618 · Globus Medical, Inc. · Jan 2017
Kyphon HV-R Bone Cement
K160983 · Medtronic, Inc. · Aug 2016
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