Cleared Traditional

NUFFIELD TOTAL KNEE

K892503 · Orthopedic Systems, Inc. · Orthopedic

May 1990

Decision

388d

Days

Class 2

Risk

About This 510(k) Submission

K892503 is an FDA 510(k) clearance for the NUFFIELD TOTAL KNEE, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on May 4, 1990, 388 days after receiving the submission on April 11, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K892503 FDA.gov
FDA Decision	Cleared SN
Date Received	April 11, 1989
Decision Date	May 04, 1990
Days to Decision	388 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560