Cleared Traditional

K163032 - Kyphon Xpede Bone Cement

K163032 is the FDA 510(k) clearance for Kyphon Xpede Bone Cement by Medtronic, Inc.. It is a Class 2 Orthopedic device (product code NDN) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K163032 · Medtronic, Inc. · Orthopedic device
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Feb 2017
Decision
119d
Days
Class 2
Risk

K163032 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, Inc. (Memphis, US). The FDA issued a Cleared decision on February 27, 2017 after a review of 119 days - within the typical 510(k) review window.

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, Inc. devices

Submission Details

510(k) Number K163032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2016
Decision Date February 27, 2017
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
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 49
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K163032.
SpineJack Expansion Kit
K181262 · Vexim SA · Aug 2018
SpineKure Kyphoplasty System
K172871 · Hanchang Co., Ltd. · May 2018
KYPHON HV-R Bone Cement
K180700 · Medtronic Sofamor Danek USA, Inc. · May 2018
CONCORD Plus Radiopaque Bone Cement
K162618 · Globus Medical, Inc. · Jan 2017
Kyphon HV-R Bone Cement
K160983 · Medtronic, Inc. · Aug 2016
KYPHON XPEDE Bone Cement
K151227 · Medtronic · Nov 2015