Cleared Traditional

ADVANCE TOTAL KNEE SYSTEM (K974328) - FDA 510(k) Clearance

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

K974328 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
73d
Days
Class 2
Risk

K974328 is an FDA 510(k) clearance for the ADVANCE TOTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on January 30, 1998 after a review of 73 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K974328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1997
Decision Date January 30, 1998
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
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 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K974328.
DURACON(R) SMALL STABILIZER TIBIAL INSERT
K974843 · Howmedica Corp. · Jun 1998
FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM
K980713 · Howmedica Corp. · May 1998
OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM
K974556 · Osteonics Corp. · Feb 1998
DEPUY AMK 3 PEG PATELLA
K972643 · Depuy, Inc. · Jan 1998
OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT
K972967 · Osteonics Corp. · Jan 1998
ADVANCE MODULAR TIBIAL COMPONENT
K973524 · Wrightmedicaltechnologyinc · Dec 1997