Cleared Traditional

KASM KNEE ARTICULATING SPACER MOLDS

K133449 · Ortho Development Corp. · Orthopedic

Feb 2014

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K133449 is an FDA 510(k) clearance for the KASM KNEE ARTICULATING SPACER MOLDS, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on February 18, 2014, 98 days after receiving the submission on November 12, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K133449 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2013
Decision Date	February 18, 2014
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

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