Cleared Traditional

K143134 - NP Cement HV (FDA 510(k) Clearance)

Also includes:
NP Cement LV NP Cement HV System NP Cement LV System

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143134 · Cossington, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
125d
Days
Class 2
Risk

K143134 is an FDA 510(k) clearance for the NP Cement HV. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Cossington, Ltd. (Kingston Upon Thames, GB). The FDA issued a Cleared decision on March 5, 2015 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 Cossington, Ltd. devices

Submission Details

510(k) Number K143134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2014
Decision Date March 05, 2015
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOD Bone Cement
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 - LOD Bone Cement

All 71
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