Cleared Traditional

Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads

K192683 · Biomet UK, Ltd. · Orthopedic

Feb 2020

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K192683 is an FDA 510(k) clearance for the Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Biomet UK, Ltd. (Brigend, GB). The FDA issued a Cleared decision on February 27, 2020, 154 days after receiving the submission on September 26, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K192683 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2019
Decision Date	February 27, 2020
Days to Decision	154 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353