Cleared Traditional

SpaceFix Shoulder Spacer

K252443 · G21, S.R.L. · Orthopedic
Sep 2025
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K252443 is an FDA 510(k) clearance for the SpaceFix Shoulder Spacer, a Bone Cement, Antibiotic (Class II — Special Controls, product code MBB), submitted by G21, S.R.L. (San Possidonio, IT). The FDA issued a Cleared decision on September 15, 2025, 42 days after receiving the submission on August 4, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K252443 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2025
Decision Date September 15, 2025
Days to Decision 42 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBB — Bone Cement, Antibiotic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027