Cleared Traditional

INSALL/BURSTEIN* II MODULAR TOTAL KNEE (K872379) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K872379 · Zimmer, Inc. · Orthopedic device
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Oct 1987
Decision
131d
Days
Class 2
Risk

K872379 is an FDA 510(k) clearance for the INSALL/BURSTEIN* II MODULAR TOTAL KNEE. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 28, 1987 after a review of 131 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 Zimmer, Inc. devices

Submission Details

510(k) Number K872379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1987
Decision Date October 28, 1987
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
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 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K872379.
PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE
K874923 · Howmedica Corp. · Oct 1988
PCA MODULAR TOTAL KNEE SYS-ALL PLAS PATELLAR COMP
K881982 · Howmedica Corp. · Jul 1988
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES
K874635 · Osteonics Corp. · Mar 1988
AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT
K873197 · Depuy, Inc. · Oct 1987
HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT
K871349 · Howmedica Corp. · Sep 1987
MODIFIED ANATOMIC MODULAR KNEE (AMK) SYSTEM
K871585 · Depuy, Inc. · Jul 1987