Cleared Traditional

K143100 - NP Cement HV Genta

Also marketed or referenced as:
NP Cement LV Genta NP Cement HV System Genta NP Cement LV System Genta

K143100 is an FDA 510(k) clearance for NP Cement HV Genta, manufactured by Cossington, Ltd.. The device is a Class 2 Orthopedic device with product code LOD cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K143100 · Cossington, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
128d
Days
Class 2
Risk

K143100 is an FDA 510(k) clearance for the NP Cement HV Genta. 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 128 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.

FDA 510(k) Submission Details - K143100

510(k) Number K143100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2014
Decision Date March 05, 2015
Days to Decision 128 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOD Device Classification - Class 2, Special Controls

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 Consultant

Mandell Horwitz Consultants, LLC
Diane Mandell Horwitz,Ph.D., RAC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LOD Bone Cement

All 71
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K143100 · NP Cement HV Genta
Download PDF FDA Summary Cossington, Ltd.