Cleared Traditional

K252443 - SpaceFix Shoulder Spacer (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252443 · G21, S.R.L. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
42d
Days
Class 2
Risk

K252443 is an FDA 510(k) clearance for the SpaceFix Shoulder Spacer. Classified as Bone Cement, Antibiotic (product code MBB), Class II - Special Controls.

Submitted by G21, S.R.L. (San Possidonio, IT). The FDA issued a Cleared decision on September 15, 2025 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all G21, S.R.L. devices

Submission Details

510(k) Number K252443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 122d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBB Bone Cement, Antibiotic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

RQMIS, Inc.
Barry Sands

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MBB Bone Cement, Antibiotic

All 18
Devices cleared under the same product code (MBB) and FDA review panel - the closest regulatory comparables to K252443.
GENTAFIX® (1, 3, 3MV)
K242216 · Teknimed Sas · Dec 2024
Hip Spacer Molds
K240856 · Osartis GmbH · Nov 2024
StageOne™ Select Hip Cement Spacer Molds
K222760 · Biomet, Inc. · Dec 2022
StageOne™ Shoulder Cement Spacer Molds
K221968 · Biomet, Inc. · Sep 2022
StageOne Knee Cement Spacer Molds
K213287 · Biomet, Inc. · Sep 2022
SpaceFlex Shoulder
K202338 · G21, S.R.L. · Feb 2021