510(k) · Cleared
ClearedOsteopal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Kulzer GmbH & Co. KG · LOD Bone Cement
Cleared on Sep 23, 2003 as substantially equivalent to P810020 (Smith & Nephew Richards, Inc., 1984) after a 183-day review. Its family tree reaches back 1 generation to 1984. 40 later devices descend from it.
- Decided
- Sep 23, 2003
- Review
- 183 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P810020 (1984). 40 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- This deviceK030903 OsteopalHeraeus Kulzer GmbH & Co. KG · 2003
- Descendant · cites it directly · 38 of its ownK050085 Osteopal VHeraeus Kulzer,GmbH · 2005
- Descendant · 2 generations on · 28 of its ownK150408 V-Steady, V-FastG21, S.R.L. · 2015
- Descendant · 3 generations on · 27 of its ownK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- Descendant · 4 generations on · 14 of its ownK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- Descendant · 5 generations on · 11 of its ownK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K050085Osteopal VHeraeus Kulzer,GmbH · 2005 · cites it directly38descendants
- K150408V-Steady, V-FastG21, S.R.L. · 2015 · 2 generations on28descendants
- K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · 3 generations on27descendants
- K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 4 generations on14descendants
- K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| 0 (this device) | K030903 | Osteopal | Heraeus Kulzer GmbH & Co. KG | 2003 | — |
| +1 | K050085 | Osteopal V | Heraeus Kulzer,GmbH | 2005 | — |
| +2 | K150408 | V-Steady, V-Fast | G21, S.R.L. | 2015 | — |
| +3 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
| +4 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| +5 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 11 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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? (1)
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 |
|---|---|---|---|
| * | P810020 | Palacos R Bone CementSummary page 1…nt Identification of the marketed device Osteopal@to OSTEOPAL" (or Palaces@ E-flow, respectively) which equivalence is claimed PMA (Merck and S.-P.) P810020 1998 Description of the device Osteopal@ is an acrylic bone cement for use in… | 1984 |
What descends from it? (40)
See all 402 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Osteopal 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 as stated in the FDA summary.
https://510kreport.com/device/K030903 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030903: Osteopal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030903
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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