Cleared Traditional

K842367 - HOWMEDICA KINEMATIC II TIBIAL WEDGE

K842367 is the FDA 510(k) clearance for HOWMEDICA KINEMATIC II TIBIAL WEDGE by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HRY) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K842367 · Howmedica Corp. · Orthopedic device
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Aug 1984
Decision
63d
Days
Class 2
Risk

K842367 is an FDA 510(k) clearance for the HOWMEDICA KINEMATIC II TIBIAL WEDGE. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on August 17, 1984 after a review of 63 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 K842367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1984
Decision Date August 17, 1984
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 K842367.
WHITESIDE ORTHOLOC (TM)
K864070 · Dow Corning Wright · Jan 1987
ARIZONA CONDYLAR TIBIAL PLATEAU
K862125 · Depuy, Inc. · Jun 1986
MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
K860133 · Depuy, Inc. · Mar 1986
UNICONDYLAR FIBER METAL KNEE
K834298 · Zimmer, Inc. · Feb 1984
P.C.A. UNICOMPARTMENTAL KNEE PROSTHES
K831143 · Howmedica Corp. · Aug 1983
IOI METAL BACKED TIBIAL COMPONENT
K821341 · Intermedics Orthopedics · Jun 1982