Cleared Traditional

K160983 - Kyphon HV-R Bone Cement

K160983 is an FDA 510(k) clearance for Kyphon HV-R Bone Cement, manufactured by Medtronic, Inc.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K160983 · Medtronic, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
139d
Days
Class 2
Risk

K160983 is an FDA 510(k) clearance for the Kyphon HV-R 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 August 24, 2016 after a review of 139 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

FDA 510(k) Submission Details - K160983

510(k) Number K160983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2016
Decision Date August 24, 2016
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
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 K160983.
DCM Kyphoplasty System
K162283 · Dragon Crown Medical Co., Ltd. · Feb 2017
CONCORD Plus Radiopaque Bone Cement
K162618 · Globus Medical, Inc. · Jan 2017
13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
K162453 · Pan Medical , Ltd. · Nov 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
KYPHON XPEDE Bone Cement
K151227 · Medtronic · Nov 2015