Cleared Traditional

POROCOAT FREEMAN/SAMUELSON TOTAL KNEE

K831441 · Depuy, Inc. · Orthopedic

Sep 1983

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K831441 is an FDA 510(k) clearance for the POROCOAT FREEMAN/SAMUELSON TOTAL KNEE, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code MBV), submitted by Depuy, Inc. (Walker, US). The FDA issued a Cleared decision on September 1, 1983, 119 days after receiving the submission on May 5, 1983. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K831441 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 05, 1983
Decision Date	September 01, 1983
Days to Decision	119 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