Cleared Traditional

implaFit? short stems

K252401 · Implantcast GmbH · Orthopedic

Mar 2026

Decision

224d

Days

Class 2

Risk

About This 510(k) Submission

K252401 is an FDA 510(k) clearance for the implaFit? short 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 March 12, 2026, 224 days after receiving the submission on July 31, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K252401 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2025
Decision Date	March 12, 2026
Days to Decision	224 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