Cleared Traditional

TRICON-M TOTAL KNEE SYSTEM

K884824 · Richards Medical Co., Inc. · Orthopedic

Nov 1989

Decision

368d

Days

Class 2

Risk

About This 510(k) Submission

K884824 is an FDA 510(k) clearance for the TRICON-M TOTAL KNEE SYSTEM, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code MBV), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on November 21, 1989, 368 days after receiving the submission on November 18, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K884824 FDA.gov
FDA Decision	Cleared SN
Date Received	November 18, 1988
Decision Date	November 21, 1989
Days to Decision	368 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	MBV — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560