Cleared Traditional

INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE (K830121) - FDA 510(k) Clearance

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

K830121 · Zimmer, Inc. · Orthopedic device
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Apr 1983
Decision
105d
Days
Class 2
Risk

K830121 is an FDA 510(k) clearance for the INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 26, 1983 after a review of 105 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 K830121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1983
Decision Date April 26, 1983
Days to Decision 105 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 122d · This submission: 105d
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 K830121.
AGC TOTAL KNEE PROSTHESIS
K833921 · Biomet, Inc. · Jan 1984
KNEE PROSTHESIS-PATELLA COMPONENT
K833411 · Johnson & Johnson Professionals, Inc. · Dec 1983
KNEE PROSTHESIS-TIBIAL COMPONENT
K830927 · Johnson & Johnson Professionals, Inc. · Jul 1983
BIO CONDYLAR TM KNEE
K810328 · Depuy, Inc. · Apr 1981
POROCOAT TM TOWNLEY ANATOMIC KNEE
K810326 · Depuy, Inc. · Mar 1981
POROUS COATED ANATOMICAL-TOTAL KNEE
K802922 · Howmedica Corp. · Dec 1980