Cleared Traditional

K142388 - Neo Total Knee System

K142388 is an FDA 510(k) clearance for Neo Total Knee System, manufactured by New Era Orthopedics, LLC. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K142388 · New Era Orthopedics, LLC · Orthopedic device
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Dec 2014
Decision
100d
Days
Class 2
Risk

K142388 is an FDA 510(k) clearance for the Neo Total Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by New Era Orthopedics, LLC (Hummelstown, US). The FDA issued a Cleared decision on December 5, 2014 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 New Era Orthopedics, LLC devices

FDA 510(k) Submission Details - K142388

510(k) Number K142388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2014
Decision Date December 05, 2014
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 840
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K142388.
Zimmer Persona Personalized Knee System
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