Cleared Traditional

BethaLoc? stem cementless HA

K223103 · Implantcast GmbH · Orthopedic

Jun 2023

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K223103 is an FDA 510(k) clearance for the BethaLoc? stem cementless HA, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Implantcast GmbH (Buxtehude, DE). The FDA issued a Cleared decision on June 20, 2023, 263 days after receiving the submission on September 30, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K223103 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2022
Decision Date	June 20, 2023
Days to Decision	263 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