Cleared Traditional

K060192 - APEX KNEE SYSTEM

K060192 is the FDA 510(k) clearance for APEX KNEE 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 141-day FDA review.

K060192 · Omni Life Science, Inc. · Orthopedic device
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Jun 2006
Decision
141d
Days
Class 2
Risk

K060192 is an FDA 510(k) clearance for the APEX KNEE 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. (Raynham, US). The FDA issued a Cleared decision on June 15, 2006 after a review of 141 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 K060192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2006
Decision Date June 15, 2006
Days to Decision 141 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
19d slower than avg
Panel avg: 122d · This submission: 141d
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

All 779
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