Cleared Traditional

Comprehensive Segmental Revision System(SRS)

K223631 · Biomet Orthopedics · Orthopedic

Jul 2023

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K223631 is an FDA 510(k) clearance for the Comprehensive Segmental Revision System(SRS), a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWT), submitted by Biomet Orthopedics (Warsaw, US). The FDA issued a Cleared decision on July 12, 2023, 219 days after receiving the submission on December 5, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3650.

Submission Details

510(k) Number	K223631 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2022
Decision Date	July 12, 2023
Days to Decision	219 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWT — Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3650