510(k) · Cleared
ClearedKYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Incorporated · PML Bone Cement, Posterior Screw Augmentation
Cleared on Jan 6, 2016 as substantially equivalent to K150460 (Medtronic Sofamor Danck USA, Inc., 2015) and 2 other predicates after a 117-day review. Its family tree reaches back 12 generations to 2004. 159 later devices descend from it.
- Decided
- Jan 6, 2016
- Review
- 117 days
- Class
- Class II
- Product code
- PML
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K040583 (2004). 82 ancestors in all, the oldest K841189 (1984). 159 later devices descend from it, 13 citing it directly.
- Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations between
- 3 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 2 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 1 generation backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- This deviceK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- Descendant · cites it directly · 106 of its ownK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
- Descendant · cites it directly · 91 of its ownK170347 CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017
- Descendant · cites it directly · 64 of its ownK171938 KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic · 2017
- Descendant · cites it directly · 50 of its ownK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 2 generations on · 48 of its ownK170543 VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017
Show all 12 generations
- Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 9 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 8 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 7 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 6 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 4 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 3 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 2 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 1 generation backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- This deviceK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
Showing 5 of 159 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 159 · See all- K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl · 2016 · cites it directly106descendants
- K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017 · cites it directly91descendants
- K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic · 2017 · cites it directly64descendants
- K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2019 · cites it directly50descendants
- K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017 · 2 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −9 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −8 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −7 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −6 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −4 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −3 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −2 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −1 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| 0 (this device) | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | 2016 | — |
| +1 | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated… | Medos International Sàrl | 2016 | — |
| +1 | K170347 | CD HORIZON™ Fenestrated Screw Set | Medtronic Sofamor Danek USA | 2017 | — |
| +1 | K171938 | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set | Medtronic | 2017 | — |
| +1 | K191148 | Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +2 | K170543 | VIPER PRIME™ Screws with Fenestrations | Medos International SARL | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 18 | 0 |
| 2005 | 9 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 15 | 0 |
| 2022 | 16 | 0 |
| 2023 | 25 | 0 |
| 2024 | 22 | 0 |
| 2025 | 20 | 0 |
| 2026 | 27 | 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 PML? 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 |
|---|---|---|---|
| * | K150460 | KYPHON (R) HV-R (R) Bone CementSummary page 5…crew System MNI Predicate Devices 1) KYPHON® HV-R® Bone Cement (Primary Predicate) K150460 KYPHON® HV-R® Bone Cement (SE 04/28/15) 2) CD HORIZON® Spinal System… | 2015 |
| * | K042025 | Modification to CD Horizon Spinal SystemSummary page 5…K150460 KYPHON® HV-R® Bone Cement (SE 04/28/15) 2) CD HORIZON® Spinal System K042025 CD HORIZON® Spinal System (SE 08/25/04) and K113174 CD HORIZON® Spinal System (SE 11/21/11)… | 2004 |
| * | K113174 | CD Horizon Spinal SystemSummary page 5…2) CD HORIZON® Spinal System K042025 CD HORIZON® Spinal System (SE 08/25/04) and K113174 CD HORIZON® Spinal System (SE 11/21/11) The predicate devices have not been subject to a design re… | 2011 |
What descends from it? (159)
See all 15913 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems | 2016 | 106 |
| K170347 | CD HORIZON™ Fenestrated Screw Set | 2017 | 91 |
| K171938 | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set | 2017 | 64 |
| K191148 | Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set | 2019 | 50 |
| K193011 | CD Horizon™ Fenestrated Screw Set | 2020 | 41 |
| K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | 2018 | 41 |
| K173487 | CarboClear® Pedicle Screw System | 2018 | 41 |
| K201362 | CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement | 2020 | 38 |
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | 2021 | 6 |
| K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | 2021 | 5 |
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 12 years and passes through 4 companies; a new generation was cleared every 4 months on median.
- 16 of the 82 ancestors have a recall of any class.
- Of its descendants, K160879 (Medos International Sàrl, 2016) has gone furthest, with 106 descendants of its own.
- 1 other device also cites its predicate K150460.
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. 2016, 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 CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw 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. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels…
Read the full statement (173 words)
When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw 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. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.
When used in conjunction with KYPHON HV-R® Fenestrated Screw Cement, the CD HORIZON® 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. CD HORIZON® Fenestrated Screws augmented with KYPHON HV-R® Fenestrated Screw 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/K152604 · printed Nov 3, 2026
Cite this page
510(k) Report. “K152604: KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K152604
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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