Cleared Traditional

Taperloc? Complete Hip Stems

K200196 · Biomet Orthopedics · Orthopedic

Dec 2020

Decision

316d

Days

Class 2

Risk

About This 510(k) Submission

K200196 is an FDA 510(k) clearance for the Taperloc? Complete Hip Stems, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Biomet Orthopedics (Warsaw, US). The FDA issued a Cleared decision on December 8, 2020, 316 days after receiving the submission on January 27, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K200196 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 2020
Decision Date	December 08, 2020
Days to Decision	316 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