Cleared Traditional

MEDIAL ROTATION KNEE SYSTEM (K020214) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020214 · Engineering Consulting Services, Inc. · Orthopedic device
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Feb 2002
Decision
35d
Days
Class 2
Risk

K020214 is an FDA 510(k) clearance for the MEDIAL ROTATION KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Engineering Consulting Services, Inc. (Prior Lake, US). The FDA issued a Cleared decision on February 26, 2002 after a review of 35 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Engineering Consulting Services, Inc. devices

Submission Details

510(k) Number K020214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2002
Decision Date February 26, 2002
Days to Decision 35 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 522
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K020214.
SCORPIO INSET PATELLAR COMPONENT
K020830 · Howmedica Osteonics Corp. · Jun 2002
ASCENT ALL-POLY PS TIBIAL BEARINGS
K021559 · Biomet, Inc. · 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
MAXIM RPG PS FEMORAL COMPONENT
K012348 · Biomet, Inc. · Aug 2001