Cleared Traditional

K871349 - HOWMEDICA KINEMATIC II MODULAR TIBIAL C...

K871349 is the FDA 510(k) clearance for HOWMEDICA KINEMATIC II MODULAR TIBIAL C... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K871349 · Howmedica Corp. · Orthopedic device
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Sep 1987
Decision
148d
Days
Class 2
Risk

K871349 is an FDA 510(k) clearance for the HOWMEDICA KINEMATIC II MODULAR 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 1, 1987 after a review of 148 days - within the typical 510(k) review window.

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 K871349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1987
Decision Date September 01, 1987
Days to Decision 148 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
26d slower than avg
Panel avg: 122d · This submission: 148d
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 765
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K871349.
INSALL/BURSTEIN* II MODULAR TOTAL KNEE
K872379 · Zimmer, Inc. · Oct 1987
AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT
K873197 · Depuy, Inc. · Oct 1987
PLUS TOTAL KNEE SYSTEM, POLY PATELLAR BUTTON
K872134 · Orthomet, Inc. · Oct 1987
CLARIFIED APPLICA. FOR LACEY CONDYLAR TOTAL KNEE
K872266 · Dow Corning Wright · Aug 1987
WHITESIDE ORTHOLOC II REV POST STAB TOTAL KNEE SY
K871776 · Dow Corning Wright · Aug 1987
GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)
K871146 · Richards Medical Co., Inc. · Jul 1987