Cleared Traditional

K872735 - HOWMEDICA KINEMATIC III STABILIZER TOTA...

K872735 is the FDA 510(k) clearance for HOWMEDICA KINEMATIC III STABILIZER TOTA... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HSX) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K872735 · Howmedica Corp. · Orthopedic device
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Aug 1987
Decision
26d
Days
Class 2
Risk

K872735 is an FDA 510(k) clearance for the HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on August 4, 1987 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 K872735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1987
Decision Date August 04, 1987
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 94
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K872735.
WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM
K881779 · Dow Corning Wright · Aug 1988
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE
K880155 · Zimmer, Inc. · Aug 1988
KIRSCHNER UNICONDYLAR KNEE SYSTEM
K873970 · Kirschner Medical Corp. · Dec 1987
INSALL/BURSTEIN(TM)* II TIBIAL WEDGES
K862632 · Zimmer, Inc. · Mar 1987
OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM
K862837 · Osteonics Corp. · Dec 1986
WHITESIDE CONDYLAR II TOTAL KNEE PROSTHESIS
K861715 · Dow Corning Wright · Jul 1986