Cleared Traditional

K896452 - KINEMAX TIBIAL STEM EXTENSION

K896452 is the FDA 510(k) clearance for KINEMAX TIBIAL STEM EXTENSION by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K896452 · Howmedica Corp. · Orthopedic device
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Jan 1990
Decision
56d
Days
Class 2
Risk

K896452 is an FDA 510(k) clearance for the KINEMAX TIBIAL STEM EXTENSION. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on January 4, 1990 after a review of 56 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 Howmedica Corp. devices

Submission Details

510(k) Number K896452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1989
Decision Date January 04, 1990
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 768
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K896452.
SHAW KNEE MODULAR TIBIAL TRAY-POROUS
K894937 · Johnson & Johnson Professionals, Inc. · Jan 1990
KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS
K895962 · Kirschner Medical Corp. · Jan 1990
WHITESIDE ORTHOLOC MODULAR-C TOTAL KNEE SYSTEM
K896045 · Dow Corning Wright · Jan 1990
ORTHOMET PLUS TOTAL KNEE SYST, TITANIUM TIBIAL PEG
K893040 · Orthomet, Inc. · Nov 1989
KINEMAX TOTAL KNEE SYSTEM FEMORAL SPACERS
K894658 · Howmedica Corp. · Oct 1989
WHITESIDE ORTHOLOC M.A. TIBIAL BASE
K894504 · Dow Corning Wright · Oct 1989