Cleared Traditional

K190216 - SpaceFlex Knee (FDA 510(k) Clearance)

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

K190216 · G21, S.R.L. · Orthopedic device
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Jun 2019
Decision
125d
Days
Class 2
Risk

K190216 is an FDA 510(k) clearance for the SpaceFlex Knee. Classified as Bone Cement, Antibiotic (product code MBB), Class II - Special Controls.

Submitted by G21, S.R.L. (San Possidomio, IT). The FDA issued a Cleared decision on June 9, 2019 after a review of 125 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all G21, S.R.L. devices

Submission Details

510(k) Number K190216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2019
Decision Date June 09, 2019
Days to Decision 125 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 122d · This submission: 125d
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 Peers - MBB Bone Cement, Antibiotic

All 18
Devices cleared under the same product code (MBB) and FDA review panel - the closest regulatory comparables to K190216.
SpaceFix Shoulder Spacer
K252443 · G21, S.R.L. · Sep 2025
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