Cleared Traditional

Biocore9 Acetabular Cup System

K212761 · Biocore9, LLC · Orthopedic

May 2022

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K212761 is an FDA 510(k) clearance for the Biocore9 Acetabular Cup System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Biocore9, LLC (Whippany, US). The FDA issued a Cleared decision on May 17, 2022, 259 days after receiving the submission on August 31, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K212761 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 2021
Decision Date	May 17, 2022
Days to Decision	259 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