Cleared Traditional

K060192 - APEX KNEE SYSTEM

K060192 is an FDA 510(k) clearance for APEX KNEE SYSTEM, manufactured by Omni Life Science, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K060192 · Omni Life Science, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K060192

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
Combination Product No
PCCP Authorized No
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.

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 886
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K060192.
TRIATHLON LOW PROFILE TIBIAL TRAY
K062037 · Howmedica Osteonics Corp. · Aug 2006
OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES
K061882 · Zimmer, Inc. · Aug 2006
BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM
K060569 · Ortho Development Corp. · Jul 2006
NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEARING ARTICULAR SURFACE COMPONENT
K060722 · Zimmer, Inc. · May 2006
VANGUARD REMOVABLE MOLDED POLY TIBIA
K060525 · Biomet Manufacturing Corp · May 2006
COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE
K053579 · Aesculap, Inc. · May 2006