Cleared Special

K080842 - APEX KNEE SYSTEM

K080842 is the FDA 510(k) clearance for APEX KNEE SYSTEM by Omni Life Science, Inc.. It is a Class 2 Orthopedic device (product code MBH) cleared through the Special 510(k) pathway after a 59-day FDA review.

K080842 · Omni Life Science, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
59d
Days
Class 2
Risk

K080842 is an FDA 510(k) clearance for the APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Omni Life Science, Inc. (Raynham, US). The FDA issued a Cleared decision on May 23, 2008 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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 Omni Life Science, Inc. devices

Submission Details

510(k) Number K080842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2008
Decision Date May 23, 2008
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 124
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K080842.
LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS
K091543 · Smith & Nephew, Inc. · Dec 2009
REGENEREX PATELLA COMPONENTS
K083782 · Biomet Manufacturing Corp · Apr 2009
ADVANCE A-CLASS TIBIAL INSERT
K081479 · Wrightmedicaltechnologyinc · Feb 2009
REGENEREX TIBIAL COMPONENTS
K080361 · Biomet, Inc. · Apr 2008
LEGION POROUS PRIMARY
K073325 · Smith & Nephew, Inc. · Dec 2007
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS
K072619 · Zimmer, Inc. · Nov 2007