Cleared Traditional

K201611 - Apex Knee System

K201611 is an FDA 510(k) clearance for Apex Knee System, manufactured by Omnilife Science. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K201611 · Omnilife Science · Orthopedic device
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Apr 2021
Decision
291d
Days
Class 2
Risk

K201611 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 Omnilife Science (Raynham, US). The FDA issued a Cleared decision on April 2, 2021 after a review of 291 days - an extended review cycle.

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 Omnilife Science devices

FDA 510(k) Submission Details - K201611

510(k) Number K201611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2020
Decision Date April 02, 2021
Days to Decision 291 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
169d slower than avg
Panel avg: 122d · This submission: 291d
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 820
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K201611.
Genius / Genuin Total Knee System
K200765 · Biorad Medisys Pvt, Ltd. · May 2021
MOBIO Total Knee System
K210483 · B-One Ortho, Corp. · Apr 2021
U2 Total Knee System, XPE Tibial Insert, PS PLUS
K210961 · United Orthopedic Corporation · Apr 2021
Persona Revision Knee System
K210551 · Zimmer, Inc. · Mar 2021
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System
K210252 · Conformis, Inc. · Feb 2021
Attune Revision Sleeve LPS Femoral Adaptors
K202248 · Depuy Ireland UC · Dec 2020