Cleared Special

K020295 - NEXGEN LPS TRABECULAR METAL MONOBLOCK T...

Also marketed or referenced as:
ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0

K020295 is the FDA 510(k) clearance for NEXGEN LPS TRABECULAR METAL MONOBLOCK T... by Implex Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Special 510(k) pathway after a 15-day FDA review.

K020295 · Implex Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
15d
Days
Class 2
Risk

K020295 is an FDA 510(k) clearance for the NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on February 12, 2002 after a review of 15 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 Implex Corp. devices

Submission Details

510(k) Number K020295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2002
Decision Date February 12, 2002
Days to Decision 15 days
Submission Type Special
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
107d faster than avg
Panel avg: 122d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 763
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K020295.
ASCENT ALL-POLY PS TIBIAL BEARINGS
K021559 · Biomet, Inc. · Jun 2002
ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED
K020383 · Ortho Development Corp. · May 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS
K012778 · Smith & Nephew, Inc. · Mar 2002
PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
K013991 · Zimmer, Inc. · Dec 2001
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
K012776 · Howmedica Osteonics Corp. · Nov 2001
THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
K012866 · Implex Corp. · Sep 2001