Cleared Traditional

K192394 - Hi-Fatigue Bone Cement

K192394 is an FDA 510(k) clearance for Hi-Fatigue Bone Cement, manufactured by Osartis GmbH. The device is a Class 2 Orthopedic device with product code LOD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K192394 · Osartis GmbH · Orthopedic device
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Dec 2019
Decision
90d
Days
Class 2
Risk

K192394 is an FDA 510(k) clearance for the Hi-Fatigue 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 December 2, 2019 after a review of 90 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 Osartis GmbH devices

FDA 510(k) Submission Details - K192394

510(k) Number K192394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2019
Decision Date December 02, 2019
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 52
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K192394.
PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
K202475 · Heraeus Medical GmbH · Nov 2020
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 G Bone Cement
K192379 · Osartis GmbH · Nov 2019
PALACOS fast R+G
K190766 · Heraeus Medical GmbH · May 2019
G3A 40 Bone Cement
K181282 · G21, S.R.L. · Jan 2019