510(k) · Cleared
ClearedV-Steady, V-Fast
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G21, S.R.L. · LOD Bone Cement
Cleared on Dec 14, 2015 as substantially equivalent to K050085 (Heraeus Kulzer,GmbH, 2005) after a 299-day review. Its family tree reaches back 3 generations to 1984. 28 later devices descend from it.
- Decided
- Dec 14, 2015
- Review
- 299 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P810020 (1984). 28 later devices descend from it, 1 citing it directly.
- Root · 3 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 2 generations backK030903 OsteopalHeraeus Kulzer GmbH & Co. KG · 2003
- 1 generation backK050085 Osteopal VHeraeus Kulzer,GmbH · 2005
- This deviceK150408 V-Steady, V-FastG21, S.R.L. · 2015
- Descendant · cites it directly · 27 of its ownK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- Descendant · 2 generations on · 14 of its ownK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- Descendant · 3 generations on · 11 of its ownK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- Descendant · 2 generations on · 5 of its ownK222789 VADER® Pedicle System, G21 CementIcotec AG · 2023 · Recalled
- Descendant · 4 generations on · 4 of its ownK242364 IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · cites it directly27descendants
- K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 2 generations on14descendants
- K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · 3 generations on11descendants
- K222789VADER® Pedicle System, G21 CementIcotec AG · 2023 · 2 generations on5descendants
- K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024 · 4 generations on4descendants
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 | K030903 | Osteopal | Heraeus Kulzer GmbH & Co. KG | 2003 | — |
| −1 | K050085 | Osteopal V | Heraeus Kulzer,GmbH | 2005 | — |
| 0 (this device) | K150408 | V-Steady, V-Fast | G21, S.R.L. | 2015 | — |
| +1 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
| +2 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| +3 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| +2 | K222789 | VADER® Pedicle System, G21 Cement | Icotec AG | 2023 | 2 |
| +4 | K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 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.
What descends from it? (28)
See all 281 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200596 | G21 Cement, VADER® Pedicle System | 2020 | 27 |
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 31 years and passes through 4 companies; a new generation was cleared every 10.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K200596 (Icotec AG, 2020) has gone furthest, with 27 descendants of its own.
- 4 other devices also cite its predicate K050085.
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
V-STEADY and V-FAST bone cements are indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.
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/K150408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150408: V-Steady, V-Fast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150408
Report an extraction error
Are you the manufacturer?
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