510(k) · Cleared
ClearedHi-Fatigue G Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osartis GmbH · LOD Bone Cement
Cleared on Nov 27, 2019 as substantially equivalent to K031673 (Heraeus Kulzer GmbH & Co. KG, 2004) and 1 other predicate after an 89-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- Nov 27, 2019
- Review
- 89 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to P810020 (1984). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 3 generations backK030086 Palacos R Bone Cement with GentamicinBiomet, Inc. · 2003
- 2 generations backK051532 Cobalt G HV Bone CementBiomet, Inc. · 2005
- 1 generation backK092150 Cobalt MV with Gentamicin (Aka Cobalt G-MV) Bone CementBiomet, Inc. · 2009
- This deviceK192379 Hi-Fatigue G Bone CementOsartis GmbH · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| −3 | K030086 | Palacos R Bone Cement with Gentamicin | Biomet, Inc. | 2003 | — |
| −2 | K051532 | Cobalt G HV Bone Cement | Biomet, Inc. | 2005 | — |
| −1 | K092150 | Cobalt MV with Gentamicin (Aka Cobalt G-MV) Bone Cement | Biomet, Inc. | 2009 | — |
| 0 (this device) | K192379 | Hi-Fatigue G Bone Cement | Osartis GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LOD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LOD device
- #1 K254107 Refobacin Bone Cement R (110034355)score 11.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031673 | Refobacin -Palacos GSummary page 5…ment 510(k) Summary 3. Predicate Device The predicate devices are as follows: - Palacos® R+G (510(k) application K031673) - Cobalt™ MV with Gentamicin Bone Cement (510(k) application K092150) 4. Device Description Hi-Fatigue G Bone Cement is… | 2004 |
| * | K092150 | Cobalt MV with Gentamicin (Aka Cobalt G-MV) Bone CementSummary page 5…cate Device The predicate devices are as follows: - Palacos® R+G (510(k) application K031673) - Cobalt™ MV with Gentamicin Bone Cement (510(k) application K092150) 4. Device Description Hi-Fatigue G Bone Cement is a PMMA, radiopaque bone cement, containing gentamicin, designed for the fixa… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 8 other devices also cite its predicate K031673.
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LOD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LOD
277in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOD
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOD
355in 2025
MAUDE reports naming product code LOD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 78 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 3 | 103 | 0 | 170 |
| 2010 | 0 | — | 0 | 291 |
| 2011 | 0 | — | 0 | 428 |
| 2012 | 0 | — | 0 | 412 |
| 2013 | 2 | — | 0 | 501 |
| 2014 | 1 | — | 1 | 465 |
| 2015 | 4 | 138 | 0 | 529 |
| 2016 | 1 | — | 0 | 615 |
| 2017 | 3 | 96 | 4 | 817 |
| 2018 | 2 | — | 0 | 1,295 |
| 2019 | 4 | 90 | 0 | 2,307 |
| 2020 | 3 | 139 | 1 | 1,294 |
| 2021 | 4 | 95 | 0 | 782 |
| 2022 | 3 | 277 | 2 | 472 |
| 2023 | 2 | — | 0 | 475 |
| 2024 | 1 | — | 0 | 492 |
| 2025 | 1 | — | 0 | 355 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
Hi-Fatigue G Bone Cement is intended for use in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone when reconstruction is necessary. The cement is intended for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192379 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192379: Hi-Fatigue G Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192379
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026