Cleared Special

ASCENT ALL-POLY PS TIBIAL BEARINGS (K021559) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K021559 · Biomet, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2002
Decision
23d
Days
Class 2
Risk

K021559 is an FDA 510(k) clearance for the ASCENT ALL-POLY PS TIBIAL BEARINGS. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 5, 2002 after a review of 23 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 Biomet, Inc. devices

Submission Details

510(k) Number K021559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2002
Decision Date June 05, 2002
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
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 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K021559.
TOTAL KNEE FEMORAL COMPONENT
K022010 · Smith & Nephew, Inc. · Aug 2002
SEARCH EVOLUTION TOTAL KNEE SYSTEM
K021313 · Aesculap, Inc. · Jul 2002
SCORPIO INSET PATELLAR COMPONENT
K020830 · Howmedica Osteonics Corp. · Jun 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