Cleared Traditional

K921640 - KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENT

K921640 is the FDA 510(k) clearance for KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENT by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K921640 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
155d
Days
Class 2
Risk

K921640 is an FDA 510(k) clearance for the KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENT. 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 September 8, 1992 after a review of 155 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Corp. devices

Submission Details

510(k) Number K921640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date September 08, 1992
Days to Decision 155 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 122d · This submission: 155d
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 766
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K921640.
FOUNDATION KNEE SYSTEM
K923277 · Encore Orthopedics, Inc. · Feb 1993
AMK MODULAR POROUS COATED TITANIUM TIBIAL TRAY
K923451 · Depuy, Inc. · Oct 1992
AXIOM TOTAL KNEE SYSTEM AND PLUS TOTAL KNEE SYSTEM
K922734 · Orthomet, Inc. · Sep 1992
DURACON ALL PLASTIC TIBIAL COMPONENT
K922048 · Howmedica Corp. · Sep 1992
AMK FIXED STEM CEMENTED TIBIAL TRAY
K922620 · Depuy, Inc. · Sep 1992
AGC AND MAXIM KNEE COMPONENTS WITH NTS
K922285 · Biomet, Inc. · Aug 1992