Cleared Traditional

K161114 - HIGH V+

K161114 is the FDA 510(k) clearance for HIGH V+ by Teknimed Sas. It is a Class 2 Orthopedic device (product code NDN) cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K161114 · Teknimed Sas · Orthopedic device
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Apr 2017
Decision
357d
Days
Class 2
Risk

K161114 is an FDA 510(k) clearance for the HIGH V+. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Teknimed Sas (L'Union, FR). The FDA issued a Cleared decision on April 12, 2017 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Teknimed Sas devices

Submission Details

510(k) Number K161114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2016
Decision Date April 12, 2017
Days to Decision 357 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
235d slower than avg
Panel avg: 122d · This submission: 357d
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 47
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K161114.
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
Kyphon Xpede Bone Cement
K163032 · Medtronic, Inc. · Feb 2017
CONCORD Plus Radiopaque Bone Cement
K162618 · Globus Medical, Inc. · Jan 2017
Kyphon HV-R Bone Cement
K160983 · Medtronic, Inc. · Aug 2016