Cleared Traditional

Arthrex iBalance BiCompartmental Arthroplasty System

K160461 · Arthrex, Inc. · Orthopedic

Apr 2016

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K160461 is an FDA 510(k) clearance for the Arthrex iBalance BiCompartmental Arthroplasty System, a Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRR), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on April 12, 2016, 53 days after receiving the submission on February 19, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3540.

Submission Details

510(k) Number	K160461 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2016
Decision Date	April 12, 2016
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KRR — Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3540