Cleared Special

OsteoRemedies Hip Spacer System

K253675 · Osteoremedies, LLC · Orthopedic
Dec 2025
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K253675 is an FDA 510(k) clearance for the OsteoRemedies Hip Spacer System, a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II — Special Controls, product code KWL), submitted by Osteoremedies, LLC (Germantown, US). The FDA issued a Cleared decision on December 23, 2025, 32 days after receiving the submission on November 21, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K253675 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2025
Decision Date December 23, 2025
Days to Decision 32 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWL — Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360

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