Cleared Traditional

K151227 - KYPHON XPEDE Bone Cement

K151227 is an FDA 510(k) clearance for KYPHON XPEDE Bone Cement, manufactured by Medtronic. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K151227 · Medtronic · Orthopedic device
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Nov 2015
Decision
193d
Days
Class 2
Risk

K151227 is an FDA 510(k) clearance for the KYPHON XPEDE Bone Cement. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Medtronic (Memphis, US). The FDA issued a Cleared decision on November 16, 2015 after a review of 193 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 Medtronic devices

FDA 510(k) Submission Details - K151227

510(k) Number K151227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2015
Decision Date November 16, 2015
Days to Decision 193 days
Submission Type Traditional
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
71d slower than avg
Panel avg: 122d · This submission: 193d
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 98
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K151227.
Kyphon HV-R Bone Cement
K160983 · Medtronic, Inc. · Aug 2016
MEDINAUT Kyphoplasty System
K153296 · Imedicom Co., Ltd. · Jul 2016
Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
K152557 · G21, S.R.L. · Feb 2016
Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
K150582 · Stryker Corporation · Jun 2015
KYPHON (R) HV-R(R) Bone Cement
K150460 · Medtronic Sofamor Danck USA, Inc. · Apr 2015
Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml
K150607 · Osseon, LLC · Apr 2015