Cleared Special

K153437 - Apex Revision Knee System

K153437 is an FDA 510(k) clearance for Apex Revision Knee System, manufactured by Omnilife Science. The device is a Class 2 Orthopedic device with product code JWH cleared through the Special 510(k) pathway after a 24-day FDA review.

K153437 · Omnilife Science · Orthopedic device
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Dec 2015
Decision
24d
Days
Class 2
Risk

K153437 is an FDA 510(k) clearance for the Apex Revision Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Omnilife Science (East Taunton, US). The FDA issued a Cleared decision on December 21, 2015 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Omnilife Science devices

FDA 510(k) Submission Details - K153437

510(k) Number K153437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2015
Decision Date December 21, 2015
Days to Decision 24 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 821
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K153437.
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