Cleared Traditional

FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP

K853730 · Protek, Inc. · Orthopedic

Feb 1986

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K853730 is an FDA 510(k) clearance for the FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code MBV), submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 18, 1986, 165 days after receiving the submission on September 6, 1985. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K853730 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 1985
Decision Date	February 18, 1986
Days to Decision	165 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