Cleared Traditional

SpaceFlex Knee (K190216) - 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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Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 Consultant

RQMIS, Inc.
Manjusha Bharadwaj

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 17
Devices cleared under the same product code (MBB) and FDA review panel - the closest regulatory comparables to K190216.
SpaceFlex Shoulder
K202338 · G21, S.R.L. · Feb 2021
SpaceFlex Knee - 80mm Size
K201960 · G21, S.R.L. · Aug 2020
G21 SpaceFlex Hip
K192041 · G21, S.R.L. · Oct 2019
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
K161273 · Biomet, Inc. · Jan 2017
StageOne Select Cement Spacer Molds for Temporary Hip Replacement
K161166 · Biomet, Inc. · Sep 2016
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
K160071 · Biomet, Inc. · Jun 2016