Cleared Traditional

KNEE PROSTHESIS-PATELLA COMPONENT (K833411) - FDA 510(k) Clearance

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

K833411 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Dec 1983
Decision
83d
Days
Class 2
Risk

K833411 is an FDA 510(k) clearance for the KNEE PROSTHESIS-PATELLA COMPONENT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on December 22, 1983 after a review of 83 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K833411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1983
Decision Date December 22, 1983
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 K833411.
ANTHRO-MODULAR TOTAL KNEE
K834432 · Zimmer, Inc. · Apr 1984
CLOUTIER II FIBER METAL TOTAL KNEE
K833363 · Zimmer, Inc. · Feb 1984
AGC TOTAL KNEE PROSTHESIS
K833921 · Biomet, Inc. · Jan 1984
KNEE PROSTHESIS-TIBIAL COMPONENT
K830927 · Johnson & Johnson Professionals, Inc. · Jul 1983
INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE
K830121 · Zimmer, Inc. · Apr 1983
BIO CONDYLAR TM KNEE
K810328 · Depuy, Inc. · Apr 1981