Cleared Traditional

XeliteMed SuperM-Fix Spinal Bone Cement

K251896 · Xelite Biomed , Ltd. · Orthopedic

Jan 2026

Decision

222d

Days

Class 2

Risk

About This 510(k) Submission

K251896 is an FDA 510(k) clearance for the XeliteMed SuperM-Fix Spinal Bone Cement, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Xelite Biomed , Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on January 28, 2026, 222 days after receiving the submission on June 20, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K251896 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2025
Decision Date	January 28, 2026
Days to Decision	222 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF