Cleared Traditional

Hoffmann LRF System

K253202 · Stryker GmbH · Orthopedic

Dec 2025

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K253202 is an FDA 510(k) clearance for the Hoffmann LRF System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Stryker GmbH (Selzach, CH). The FDA issued a Cleared decision on December 19, 2025, 84 days after receiving the submission on September 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K253202 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2025
Decision Date	December 19, 2025
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030