510(k) · Cleared
ClearedHi-Fatigue 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 Dec 2, 2019 as substantially equivalent to K030902 (Heraeus Kulzer GmbH & Co. KG, 2003) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Dec 2, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P810020 (1984). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 2 generations backK051496 Cobalt Bone CementBiomet, Inc. · 2005 · Recalled
- 1 generation backK091608 Cobalt MV Bone CementBiomet Manufacturing Corp · 2009 · Recalled
- This deviceK192394 Hi-Fatigue Bone CementOsartis GmbH · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| −2 | K051496 | Cobalt Bone Cement | Biomet, Inc. | 2005 | 4 |
| −1 | K091608 | Cobalt MV Bone Cement | Biomet Manufacturing Corp | 2009 | 2 |
| 0 (this device) | K192394 | Hi-Fatigue Bone Cement | Osartis GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K030902 | Palacos RSummary page 5…Cement 510(k) Summary 3. Predicate Device The predicate devices are as follows: - Palacos® R (510(k) application K030902) - Cobalt™ MV Bone Cement (510(k) application K091608) 4. Device Description Hi-Fatigue Bone Cement is a PMMA, radiopaqu… | 2003 |
| * | K091608 | Cobalt MV Bone CementSummary page 5…mmary 3. Predicate Device The predicate devices are as follows: - Palacos® R (510(k) application K030902) - Cobalt™ MV Bone Cement (510(k) application K091608) 4. Device Description Hi-Fatigue Bone Cement is a PMMA, radiopaque bone cement, designed for the fixation of prothesis to the… | 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 4 companies; a new generation was cleared every 10.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 8 other devices also cite its predicate K030902.
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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192394: Hi-Fatigue 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/K192394
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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