Cleared Traditional

K833363 - CLOUTIER II FIBER METAL TOTAL KNEE

K833363 is an FDA 510(k) clearance for CLOUTIER II FIBER METAL TOTAL KNEE, 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 139-day FDA review.

K833363 · Zimmer, Inc. · Orthopedic device
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Feb 1984
Decision
139d
Days
Class 2
Risk

K833363 is an FDA 510(k) clearance for the CLOUTIER II FIBER METAL TOTAL KNEE. 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 February 13, 1984 after a review of 139 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 - K833363

510(k) Number K833363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1983
Decision Date February 13, 1984
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
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 K833363.
TRICON-P TIBIAL COMPONENT
K843241 · Richards Medical Co., Inc. · Sep 1984
TRICON M TIBIAL COMPONENT
K843242 · Richards Medical Co., Inc. · Sep 1984
ANTHRO-MODULAR TOTAL KNEE
K834432 · Zimmer, Inc. · Apr 1984
PATELLA PROSTHESIS
K840100 · Techmedica, Inc. · Feb 1984
AGC TOTAL KNEE PROSTHESIS
K833921 · Biomet, Inc. · Jan 1984
KNEE PROSTHESIS-PATELLA COMPONENT
K833411 · Johnson & Johnson Professionals, Inc. · Dec 1983