Cleared Traditional

K131472 - APEX KNEE MODULAR TIBIA SYSTEM

K131472 is the FDA 510(k) clearance for APEX KNEE MODULAR TIBIA SYSTEM by Omni Life Science, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K131472 · Omni Life Science, Inc. · Orthopedic device
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Oct 2013
Decision
139d
Days
Class 2
Risk

K131472 is an FDA 510(k) clearance for the APEX KNEE MODULAR TIBIA SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Omni Life Science, Inc. (East Taunton, US). The FDA issued a Cleared decision on October 8, 2013 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 888.3560 - 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 Omni Life Science, Inc. devices

Submission Details

510(k) Number K131472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2013
Decision Date October 08, 2013
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

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