Cleared Traditional

K181282 - G3A 40 Bone Cement

K181282 is an FDA 510(k) clearance for G3A 40 Bone Cement, 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 239-day FDA review.

K181282 · G21, S.R.L. · Orthopedic device
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Jan 2019
Decision
239d
Days
Class 2
Risk

K181282 is an FDA 510(k) clearance for the G3A 40 Bone Cement. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by G21, S.R.L. (San Possidomio, IT). The FDA issued a Cleared decision on January 9, 2019 after a review of 239 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 - K181282

510(k) Number K181282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2018
Decision Date January 09, 2019
Days to Decision 239 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 122d · This submission: 239d
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 Consultant

RQMIS, Inc.
Barry E 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 - LOD Bone Cement

All 52
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K181282.
Hi-Fatigue Bone Cement
K192394 · Osartis GmbH · Dec 2019
Hi-Fatigue G Bone Cement
K192379 · Osartis GmbH · Nov 2019
PALACOS fast R+G
K190766 · Heraeus Medical GmbH · May 2019
PALACOS MV
K182260 · Heraeus Medical GmbH · Sep 2018
OrthoSteady G Bone Cement
K173494 · G21, S.R.L. · Mar 2018
Biomet Bone Cement R
K172408 · Biomet, Inc. · Oct 2017