Cleared Traditional

K830121 - INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE

K830121 is an FDA 510(k) clearance for INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 105-day FDA review.

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

FDA 510(k) Submission Details - K830121

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.

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 787
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
101 TOTAL CONDYLAR KNEE SYSTEM
K813598 · Intermedics Orthopedics · Feb 1982
BIO CONDYLAR TM KNEE
K810328 · Depuy, Inc. · Apr 1981
POROCOAT TM TOWNLEY ANATOMIC KNEE
K810326 · Depuy, Inc. · Mar 1981