Cleared Traditional

PROCOTYL? PRIME Acetabular Cup System

K170444 · Microport Orthopedics, Inc. · Orthopedic
Jun 2017
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K170444 is an FDA 510(k) clearance for the PROCOTYL? PRIME Acetabular Cup System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on June 26, 2017, 132 days after receiving the submission on February 14, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number K170444 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2017
Decision Date June 26, 2017
Days to Decision 132 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3358

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