510(k) · Cleared
ClearedNuVasive Reline Fenestrated Screws, High V+ Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · PML Bone Cement, Posterior Screw Augmentation
Cleared on Nov 28, 2018 as substantially equivalent to K160989 (Nu Vasive, Incorporated, 2016) and 2 other predicates after a 275-day review. Its family tree reaches back 18 generations to 2004. 1 of the 216 devices in its family, counting itself, has a Class I recall. 41 later devices descend from it.
- Decided
- Nov 28, 2018
- Review
- 275 days
- Class
- Class II
- Product code
- PML
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K040583 (2004). 174 ancestors in all, the oldest K841189 (1984). 41 later devices descend from it, 3 citing it directly. 1 of the 216 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations between
- 3 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 2 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 1 generation backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- This deviceK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
- Descendant · cites it directly · 28 of its ownK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
- Descendant · 2 generations on · 27 of its ownK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- Descendant · cites it directly · 14 of its ownK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- Descendant · 2 generations on · 11 of its ownK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- Descendant · cites it directly · 11 of its ownK182974 NuVasive Reline SystemNu Vasive, Incorporated · 2019
Show all 18 generations
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 6 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 5 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 4 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 3 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 2 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 1 generation backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- This deviceK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
Most influential descendants
Showing 5 of 41 · See all- K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019 · cites it directly28descendants
- K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · 2 generations on27descendants
- K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · cites it directly14descendants
- K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · 2 generations on11descendants
- K182974NuVasive Reline SystemNu Vasive, Incorporated · 2019 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −15 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −13 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −10 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −9 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −8 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −7 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −6 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −5 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −4 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −3 | K141604 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −2 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| −1 | K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| 0 (this device) | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018 | — |
| +1 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 2019 | — |
| +2 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
| +1 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| +2 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| +1 | K182974 | NuVasive Reline System | Nu Vasive, Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 14 | 0 |
| 2001 | 13 | 0 |
| 2002 | 7 | 0 |
| 2003 | 12 | 0 |
| 2004 | 24 | 0 |
| 2005 | 16 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 8 | 0 |
| 2010 | 6 | 1 |
| 2011 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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? (3)
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 |
|---|---|---|---|
| * | K160989 | NuVasive® Reline® SystemSummary page 4… Predicate Devices The subject NuVasive Reline Fenestrated Screws are substantially equivalent to the primary predicate device, the NuVasive Reline System (K160989) and the additional predicaWe device, Medtronic Sofamor Danek USA, Inc., CD HORIZON Fenestrated Screw Set (K152604).… | 2016 |
| * | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetSummary page 4…dicate device, the NuVasive Reline System (K160989) and the additional predicaWe device, Medtronic Sofamor Danek USA, Inc., CD HORIZON Fenestrated Screw Set (K152604). The subject High V+ Bone Cement is substantially equivalent to the predicate device, the Teknimed High V+ (K161114)… | 2016 |
| * | K161114 | HIGH V+Summary page 4…, CD HORIZON Fenestrated Screw Set (K152604). The subject High V+ Bone Cement is substantially equivalent to the predicate device, the Teknimed High V+ (K161114) and the additional predicate device, Medtronic Sofamor Danek USA, Inc., KYPHON HV-R Fenestrated Screw Cement (K152604). '… | 2017 |
What descends from it? (41)
See all 413 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 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 6 months on median.
- 28 of the 174 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K190526 (CarboFix Orthopedics, Ltd., 2019) has gone furthest, with 28 descendants of its own.
- 3 other devices also cite its predicate K160989.
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. 2018, 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?
NuVasive® Reline Fenestrated Screws When used in conjunction with High V+ Bone Cement, the NuVasive Reline Fenestrated 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. NuVasive Reline Fenestrated Screws augmented with…
Read the full statement (177 words)
NuVasive® Reline Fenestrated Screws
When used in conjunction with High V+ Bone Cement, the NuVasive Reline Fenestrated 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. NuVasive Reline Fenestrated Screws augmented with High V+ Bone Cement are for use at spinal levels where
the structural integrity of the spine is not severely compromised.
High V+ Bone Cement
When used in conjunction with the NuVasive Reline Fenestrated 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180498: NuVasive Reline Fenestrated Screws, High V+ 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/K180498
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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