Cleared Traditional

K162618 - CONCORD Plus Radiopaque Bone Cement

K162618 is an FDA 510(k) clearance for CONCORD Plus Radiopaque Bone Cement, manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K162618 · Globus Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
125d
Days
Class 2
Risk

K162618 is an FDA 510(k) clearance for the CONCORD Plus Radiopaque Bone Cement. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on January 23, 2017 after a review of 125 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 Globus Medical, Inc. devices

FDA 510(k) Submission Details - K162618

510(k) Number K162618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2016
Decision Date January 23, 2017
Days to Decision 125 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 slower than avg
Panel avg: 122d · This submission: 125d
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 96
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K162618.
HIGH V+
K161114 · Teknimed Sas · Apr 2017
Kyphon Xpede Bone Cement
K163032 · Medtronic, Inc. · Feb 2017
DCM Kyphoplasty System
K162283 · Dragon Crown Medical Co., Ltd. · Feb 2017
13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
K162453 · Pan Medical , Ltd. · Nov 2016
Kyphon HV-R Bone Cement
K160983 · Medtronic, Inc. · Aug 2016
MEDINAUT Kyphoplasty System
K153296 · Imedicom Co., Ltd. · Jul 2016