Cleared Traditional

K871349 - HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT

K871349 is an FDA 510(k) clearance for HOWMEDICA KINEMATIC II MODULAR TIBIAL C..., manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K871349

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.

JWH Device Classification - Class 2, Special Controls

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 885
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