Cleared Traditional

PROFEMUR TL2 Stems

K191632 · Microport Orthopedics, Inc. · Orthopedic
Oct 2019
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K191632 is an FDA 510(k) clearance for the PROFEMUR TL2 Stems, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on October 7, 2019, 110 days after receiving the submission on June 19, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number K191632 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2019
Decision Date October 07, 2019
Days to Decision 110 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

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