Cleared Traditional

K810060 - P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH

K810060 is the FDA 510(k) clearance for P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HRY) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K810060 · Howmedica Corp. · Orthopedic device
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Apr 1981
Decision
84d
Days
Class 2
Risk

K810060 is an FDA 510(k) clearance for the P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Howmedica Corp. (Walker, US). The FDA issued a Cleared decision on April 7, 1981 after a review of 84 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 Howmedica Corp. devices

Submission Details

510(k) Number K810060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1981
Decision Date April 07, 1981
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 72
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K810060.
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
TOWNLEY UNICONDYLAR KNEE
K812012 · Depuy, Inc. · Sep 1981
MILLER MULTI-RADIUS TOTAL KNEE
K810616 · Zimmer, Inc. · Mar 1981
RANAWAT ESF TOTAL CONDYLAR KNEE
K802446 · Howmedica Corp. · Oct 1980
RMC KNEE METAL SHOE TIBIAL COMPONENTS
K792619 · Richard'S Medical Equip., Inc. · Feb 1980