Cleared Traditional

BKS Revision Sleeves System

K181569 · Ortho Development Corporation · Orthopedic

Oct 2018

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K181569 is an FDA 510(k) clearance for the BKS Revision Sleeves System, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on October 12, 2018, 120 days after receiving the submission on June 14, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K181569 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 2018
Decision Date	October 12, 2018
Days to Decision	120 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