Cleared Traditional

Balanced Knee System Uni

K211471 · Ortho Development Corporation · Orthopedic

Dec 2021

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K211471 is an FDA 510(k) clearance for the Balanced Knee System Uni, a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSX), submitted by Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on December 16, 2021, 219 days after receiving the submission on May 11, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3520.

Submission Details

510(k) Number	K211471 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 2021
Decision Date	December 16, 2021
Days to Decision	219 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3520