Cleared Traditional

K150408 - V-STEADY

K150408 is an FDA 510(k) clearance for V-STEADY, manufactured by G21, S.R.L.. The device is a Class 2 Orthopedic device with product code LOD cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K150408 · G21, S.R.L. · Orthopedic device
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Dec 2015
Decision
299d
Days
Class 2
Risk

K150408 is an FDA 510(k) clearance for the V-STEADY, V-FAST. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by G21, S.R.L. (San Possidonio, IT). The FDA issued a Cleared decision on December 14, 2015 after a review of 299 days - an extended review 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: 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

FDA 510(k) Submission Details - K150408

510(k) Number K150408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2015
Decision Date December 14, 2015
Days to Decision 299 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
177d slower than avg
Panel avg: 122d · This submission: 299d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOD Device Classification - Class 2, Special Controls

Product Code LOD Bone Cement
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 - LOD Bone Cement

All 53
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K150408.
Biomet Bone Cement R
K172408 · Biomet, Inc. · Oct 2017
TRAUMACEM™ V+ Injectable Bone Cement
K170802 · Synthes USA Products, LLC · Sep 2017
Refobacin Bone Cement R
K171540 · Biomet, Inc. · Aug 2017
COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
K092150 · Biomet, Inc. · Oct 2009
COBALT MV BONE CEMENT
K091608 · Biomet Manufacturing Corp · Sep 2009
SMARTSET MV BONE CEMENT
K081155 · DePuy Orthopaedics, Inc. · May 2008