Cleared Traditional

K953439 - ULTRACK TOTAL KNEE SYSTEM

K953439 is an FDA 510(k) clearance for ULTRACK TOTAL KNEE SYSTEM, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K953439 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
193d
Days
Class 2
Risk

K953439 is an FDA 510(k) clearance for the ULTRACK 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, 1996 after a review of 193 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K953439

510(k) Number K953439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1995
Decision Date January 30, 1996
Days to Decision 193 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
71d slower than avg
Panel avg: 122d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

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 894
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K953439.
OSTEONICS N2/VAC PACKAGING PROCESS
K955421 · Osteonics Corp. · Feb 1996
GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM
K953274 · Smith & Nephew Richards, Inc. · Feb 1996
PROFIX POSTERIOR-STABILIZED KNEE SYSTEM
K954909 · Smith & Nephew Richards, Inc. · Jan 1996
DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT
K954684 · Depuy, Inc. · Jan 1996
DARWIN KNEE SYSTEM (TC3)
K952830 · Johnson & Johnson Professionals, Inc. · Jan 1996
DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT
K954138 · Howmedica Corp. · Nov 1995