Cleared Traditional

Hi-Fatigue G Bone Cement (K192379) - FDA 510(k) Clearance

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

K192379 · Osartis GmbH · Orthopedic device
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Nov 2019
Decision
89d
Days
Class 2
Risk

K192379 is an FDA 510(k) clearance for the Hi-Fatigue G Bone Cement. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Osartis GmbH (Dieburg, DE). The FDA issued a Cleared decision on November 27, 2019 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osartis GmbH devices

Submission Details

510(k) Number K192379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2019
Decision Date November 27, 2019
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 48
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K192379.
G1 40 Radiopaque Bone Cement
K193059 · G21, S.R.L. · Mar 2020
G3 40 Radiopaque Bone Cement
K193061 · G21, S.R.L. · Mar 2020
Hi-Fatigue Bone Cement
K192394 · Osartis GmbH · Dec 2019
PALACOS fast R+G
K190766 · Heraeus Medical GmbH · May 2019
G3A 40 Bone Cement
K181282 · G21, S.R.L. · Jan 2019
PALACOS MV
K182260 · Heraeus Medical GmbH · Sep 2018