Cleared Traditional

K904448 - TOWNLEY TOTAL KNEE (TTK)

K904448 is the FDA 510(k) clearance for TOWNLEY TOTAL KNEE (TTK) by Biopro, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K904448 · Biopro, Inc. · Orthopedic device
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Jul 1991
Decision
292d
Days
Class 2
Risk

K904448 is an FDA 510(k) clearance for the TOWNLEY TOTAL KNEE (TTK). Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on July 17, 1991 after a review of 292 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 Biopro, Inc. devices

Submission Details

510(k) Number K904448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1990
Decision Date July 17, 1991
Days to Decision 292 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 122d · This submission: 292d
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 781
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K904448.
ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY
K910940 · Depuy, Inc. · Sep 1991
AGC REVISION KNEE PROTHESIS
K912245 · Biomet, Inc. · Aug 1991
OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP
K912147 · Osteonics Corp. · Aug 1991
MG II POROUS COBAL T-CHROME FEMORAL COMPONENT
K911572 · Zimmer, Inc. · Jul 1991
PCA MTK II TOTAL KNEE SYSTEM
K910235 · Howmedica Corp. · Jun 1991
OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS
K910990 · Osteonics Corp. · Jun 1991