Cleared Traditional

implaFit? hip stems

K210678 · Implantcast GmbH · Orthopedic

Aug 2022

Decision

530d

Days

Class 2

Risk

About This 510(k) Submission

K210678 is an FDA 510(k) clearance for the implaFit? hip stems, 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 August 17, 2022, 530 days after receiving the submission on March 5, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K210678 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 2021
Decision Date	August 17, 2022
Days to Decision	530 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