510(k) · Cleared
ClearedHigh V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CarboFix Orthopedics, Ltd. · PML Bone Cement, Posterior Screw Augmentation
Cleared on Sep 19, 2019 as substantially equivalent to K161114 (Teknimed Sas, 2017) and 3 other predicates after a 199-day review. Its family tree reaches back 19 generations to 2004. 1 of the 316 devices in its family, counting itself, has a Class I recall. 28 later devices descend from it.
- Decided
- Sep 19, 2019
- Review
- 199 days
- Class
- Class II
- Product code
- PML
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K040583 (2004). 287 ancestors in all, the oldest K841189 (1984). 28 later devices descend from it, 2 citing it directly. 1 of the 316 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations between
- 3 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 2 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- 1 generation backK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
- This deviceK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
- 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
Show all 19 generations
- Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 7 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 6 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 5 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 4 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 3 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 2 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- 1 generation backK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
- This deviceK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100952 Modification to Synthes Matrix System5 generations back · 2010
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 |
|---|---|---|---|---|---|
| −19 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −16 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −15 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −14 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −12 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −11 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −10 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −9 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −8 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −7 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −6 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −5 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −4 | K141604 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −3 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| −2 | K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| −1 | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018 | — |
| 0 (this device) | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 2019 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 9 | 0 |
| 1996 | 8 | 0 |
| 1997 | 8 | 0 |
| 1998 | 14 | 0 |
| 1999 | 14 | 0 |
| 2000 | 18 | 0 |
| 2001 | 18 | 0 |
| 2002 | 17 | 0 |
| 2003 | 18 | 0 |
| 2004 | 27 | 0 |
| 2005 | 22 | 0 |
| 2006 | 15 | 0 |
| 2007 | 12 | 0 |
| 2008 | 12 | 0 |
| 2009 | 11 | 0 |
| 2010 | 7 | 1 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
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.
1 device in this family has a Class I recall. 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 PML device
- #1 K200596 G21 Cement, VADER® Pedicle Systemscore 24.9 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K161114 | HIGH V+Summary page 5…0 Panel Orthopaedic Orthopaedic Predicate Devices The subject High V+ Bone Cement is substantially equivalent to the primary predicate device - High V+ (Teknimed® SAS; K161114); and to the additional predicate device - Incorporated; K180498). High V+ Bone Cement (NuVasive, K190526… | 2017 |
| * | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone CementSummary page 5…+ Bone Cement is substantially equivalent to the primary predicate device - High V+ (Teknimed® SAS; K161114); and to the additional predicate device - Incorporated; K180498). High V+ Bone Cement (NuVasive, K190526 - Page 2 of 4 CARBOFI1X ORTHOPEDICS LTD. CARBOCLEAR® PEDICLE SCREW S… | 2018 |
| * | K173487 | CarboClear® Pedicle Screw SystemSummary page 6…W SYSTEM The subject CarboClear Fenestrated Pedicle Screws are substantially equivalent to the predicate device - CarboClear® Pedicle Screws (CarboFix Orthopedics Ltd.; K173487, K182377); and to the additional predicate devices - NuVasive® Reline® Fenestrated Screws (NuVasive, Incorporated; K180498). Ind… | 2018 |
| * | K182377 | CarboClear® Pedicle Screw SystemSummary page 6…The subject CarboClear Fenestrated Pedicle Screws are substantially equivalent to the predicate device - CarboClear® Pedicle Screws (CarboFix Orthopedics Ltd.; K173487, K182377); and to the additional predicate devices - NuVasive® Reline® Fenestrated Screws (NuVasive, Incorporated; K180498). Indications… | 2018 |
What descends from it? (28)
See all 282 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 6 months on median.
- 36 of the 287 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K200596 (Icotec AG, 2020) has gone furthest, with 27 descendants of its own.
- 1 other device also cites its predicate K161114.
How does its category compare?
All PML devicesPML Bone Cement, Posterior Screw Augmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PML
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PML
116in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PML
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PML
55in 2025
MAUDE reports naming product code PML, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 35 |
| 2020 | 3 | 182 | 0 | 27 |
| 2021 | 1 | — | 0 | 32 |
| 2022 | 2 | — | 0 | 12 |
| 2023 | 3 | 116 | 2 | 18 |
| 2024 | 1 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 55 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
When used in conjunction with the CarboClear Fenestrated Pedicle Screws, High V+ Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. High V+ Bone Cement is limited to use at spinal levels where the structural integrity…
Read the full statement (169 words)
When used in conjunction with the CarboClear Fenestrated Pedicle Screws, High V+ Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. High V+ Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.
When used in conjunction with High V+ Bone Cement, the CarboClear Fenestrated Pedicle Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CarboClear Fenestrated Pedicle Screws augmented with High V+ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
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/K190526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190526: High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190526
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