Cleared Traditional

KNEE PROSTHESIS-TIBIAL COMPONENT (K830927) - FDA 510(k) Clearance

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

K830927 · Johnson & Johnson Professionals, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1983
Decision
118d
Days
Class 2
Risk

K830927 is an FDA 510(k) clearance for the KNEE PROSTHESIS-TIBIAL 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 July 19, 1983 after a review of 118 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K830927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1983
Decision Date July 19, 1983
Days to Decision 118 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
4d faster than avg
Panel avg: 122d · This submission: 118d
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 K830927.
CLOUTIER II FIBER METAL TOTAL KNEE
K833363 · Zimmer, Inc. · Feb 1984
AGC TOTAL KNEE PROSTHESIS
K833921 · Biomet, Inc. · Jan 1984
KNEE PROSTHESIS-PATELLA COMPONENT
K833411 · Johnson & Johnson Professionals, Inc. · Dec 1983
INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE
K830121 · Zimmer, Inc. · Apr 1983
BIO CONDYLAR TM KNEE
K810328 · Depuy, Inc. · Apr 1981
POROCOAT TM TOWNLEY ANATOMIC KNEE
K810326 · Depuy, Inc. · Mar 1981