Cleared Traditional

K843241 - TRICON-P TIBIAL COMPONENT

K843241 is an FDA 510(k) clearance for TRICON-P TIBIAL COMPONENT, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K843241 · Richards Medical Co., Inc. · Orthopedic device
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Sep 1984
Decision
50d
Days
Class 2
Risk

K843241 is an FDA 510(k) clearance for the TRICON-P TIBIAL COMPONENT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1984 after a review of 50 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K843241

510(k) Number K843241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1984
Decision Date September 26, 1984
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
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 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K843241.
THE P.C.A. DOME PATELLA COMPONENT
K852059 · Howmedica Corp. · Jul 1985
RMC POSTERIOR STABILIZED KNEE SYSTEM
K851231 · Richards Medical Co., Inc. · May 1985
POROUS COATED TITANIUM KNEE PROSTHES-
K843907 · Johnson & Johnson Professionals, Inc. · Jan 1985
TRICON M TIBIAL COMPONENT
K843242 · Richards Medical Co., Inc. · Sep 1984
ANTHRO-MODULAR TOTAL KNEE
K834432 · Zimmer, Inc. · Apr 1984
CLOUTIER II FIBER METAL TOTAL KNEE
K833363 · Zimmer, Inc. · Feb 1984