Cleared Traditional

Platform? Acetabular System

K220483 · Total Joint Orthopedics, Inc. · Orthopedic

Sep 2022

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K220483 is an FDA 510(k) clearance for the Platform? Acetabular System, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Total Joint Orthopedics, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 23, 2022, 217 days after receiving the submission on February 18, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K220483 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 2022
Decision Date	September 23, 2022
Days to Decision	217 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