Hi-Fatigue Bone Cement— 510(k) K192394

Name: FDA 510(k) clearance K192394
Creator: U.S. Food and Drug Administration
Published: 2019-12-02

Substantially Equivalent

Osartis GmbH

FDA 510(k) clearance K192394 for Hi-Fatigue Bone Cement, Substantially Equivalent on 2019-12-02. Applicant: Osartis GmbH. Device class: 2.

Clearance details

Applicant: Osartis GmbH
Product code: Code LOD
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2019-09-03
Decision date: 2019-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dieburg, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code LOD

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K254107 — Refobacin Bone Cement R (110034355)2026-04-15
K250760 — SPECTRUM GV Bone Cement2025-04-02
K241674 — OSTEOPAL® V2024-12-05
K231556 — SPECTRUM® GV Bone Cement2023-12-20
K211163 — Bone Cement Genta, Bone Cement HV, Bone Cement LV2023-01-09

More clearances from Osartis GmbH

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K240856 — Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds2024-11-20
K202458 — BonOs Inject, Pedicle screw kits, Cement pusher2021-05-18
K210120 — BonOs HV, BonOs MV, BonOs LV2021-03-19
K210125 — BonOs HV Genta, BonOs MV Genta, BonOs LV Genta2021-03-19
K192379 — Hi-Fatigue G Bone Cement2019-11-27

Adverse events under product code LOD

product code LOD

Death: 44
Injury: 3,004
Malfunction: 895
Other: 4
Total: 3,947

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.