Cleared Special

K201960 - SpaceFlex Knee - 80mm Size (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201960 · G21, S.R.L. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
30d
Days
Class 2
Risk

K201960 is an FDA 510(k) clearance for the SpaceFlex Knee - 80mm Size. 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 August 13, 2020 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all G21, S.R.L. devices

Submission Details

510(k) Number K201960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2020
Decision Date August 13, 2020
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K201960.
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