Cleared Traditional

POROCOAT TM TOWNLEY ANATOMIC KNEE (K810326) - FDA 510(k) Clearance

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

K810326 · Depuy, Inc. · Orthopedic device
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Mar 1981
Decision
30d
Days
Class 2
Risk

K810326 is an FDA 510(k) clearance for the POROCOAT TM TOWNLEY ANATOMIC KNEE. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Depuy, Inc. (Walker, US). The FDA issued a Cleared decision on March 11, 1981 after a review of 30 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 Depuy, Inc. devices

Submission Details

510(k) Number K810326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1981
Decision Date March 11, 1981
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 K810326.
KNEE PROSTHESIS-TIBIAL COMPONENT
K830927 · Johnson & Johnson Professionals, Inc. · Jul 1983
INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE
K830121 · Zimmer, Inc. · Apr 1983
BIO CONDYLAR TM KNEE
K810328 · Depuy, Inc. · Apr 1981
POROUS COATED ANATOMICAL-TOTAL KNEE
K802922 · Howmedica Corp. · Dec 1980
THE HOWMEDICA KINEMATIC KNEE SYSTEM
K792089 · Howmedica Corp. · May 1980
PROTHESIS, RETAINED GEOMETRIC KNEE
K790219 · Zimmer, Inc. · May 1979