Cleared Traditional

TOWNLEY UNICONDYLAR KNEE (K812012) - FDA 510(k) Clearance

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

K812012 · Depuy, Inc. · Orthopedic device
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Sep 1981
Decision
69d
Days
Class 2
Risk

K812012 is an FDA 510(k) clearance for the TOWNLEY UNICONDYLAR KNEE. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Depuy, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1981 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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 K812012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1981
Decision Date September 24, 1981
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 50
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K812012.
P.C.A. UNICOMPARTMENTAL KNEE PROSTHES
K831143 · Howmedica Corp. · Aug 1983
BARD CONTOUR LINK S.K.I. KNEE SYS
K820002 · C.R. Bard, Inc. · May 1982
HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE
K820030 · Howmedica Corp. · Feb 1982
P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH
K810060 · Howmedica Corp. · Apr 1981
MILLER MULTI-RADIUS TOTAL KNEE
K810616 · Zimmer, Inc. · Mar 1981
RANAWAT ESF TOTAL CONDYLAR KNEE
K802446 · Howmedica Corp. · Oct 1980