Cleared Traditional

K884824 - TRICON-M TOTAL KNEE SYSTEM

K884824 is an FDA 510(k) clearance for TRICON-M TOTAL KNEE SYSTEM, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Orthopedic device with product code MBV cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K884824 · Richards Medical Co., Inc. · Orthopedic device
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Nov 1989
Decision
368d
Days
Class 2
Risk

K884824 is an FDA 510(k) clearance for the TRICON-M TOTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer (product code MBV), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on November 21, 1989 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K884824

510(k) Number K884824 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 18, 1988
Decision Date November 21, 1989
Days to Decision 368 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
246d slower than avg
Panel avg: 122d · This submission: 368d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBV Device Classification - Class 2, Special Controls

Product Code MBV Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, 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 - MBV Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer

All 11
Devices cleared under the same product code (MBV) and FDA review panel - the closest regulatory comparables to K884824.
OFFSET TIBIAL TRAY
K010212 · Biomet, Inc. · Feb 2001
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE
K873429 · Protek, Inc. · Oct 1987
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP
K853730 · Protek, Inc. · Feb 1986
TRICON M TOTAL KNEE SYSTEM
K833200 · Richards Medical Co., Inc. · Nov 1983
POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
K831441 · Depuy, Inc. · Sep 1983
RMC TOTAL KNEE SYSTEM
K823837 · Richard'S Medical Equip., Inc. · Mar 1983