510(k) · Cleared
ClearedMedtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone 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, Inc. · PML Bone Cement, Posterior Screw Augmentation
Cleared on Sep 12, 2019 as substantially equivalent to K152604 (Medtronic Sofamor Danek USA, Incorporated, 2016) and 5 other predicates after a 135-day review. Its family tree reaches back 18 generations to 2004. 50 later devices descend from it.
- Decided
- Sep 12, 2019
- Review
- 135 days
- Class
- Class II
- Product code
- PML
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 18 generations to K040583 (2004). 174 ancestors in all, the oldest K841189 (1984). 50 later devices descend from it, 5 citing it directly.
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations between
- 3 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
- This deviceK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
- Descendant · cites it directly · 41 of its ownK193011 CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020
- Descendant · cites it directly · 38 of its ownK201362 CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System…Medtronic · 2020
- Descendant · 2 generations on · 34 of its ownK210637 CD Horizon™ Spinal SystemMedtronic · 2021
- Descendant · 2 generations on · 20 of its ownK221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion…Medtronic Sofamor Danek USA, Inc. · 2022
- Descendant · 3 generations on · 20 of its ownK221244 CD Horizon™ Spinal SystemMedtronic · 2022
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 backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 4 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 3 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
- This deviceK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020 · cites it directly41descendants
- K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic · 2020 · cites it directly38descendants
- K210637CD Horizon™ Spinal SystemMedtronic · 2021 · 2 generations on34descendants
- K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc. · 2022 · 2 generations on20descendants
- K221244CD Horizon™ Spinal SystemMedtronic · 2022 · 3 generations on20descendants
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 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −4 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −3 | K143019 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −2 | K153463 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −1 | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the… | Medtronic Sofamor Danek | 2017 | — |
| 0 (this device) | K191148 | Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +1 | K193011 | CD Horizon™ Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
| +1 | K201362 | CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™… | Medtronic | 2020 | — |
| +2 | K210637 | CD Horizon™ Spinal System | Medtronic | 2021 | — |
| +2 | K221646 | CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD… | Medtronic Sofamor Danek USA, Inc. | 2022 | — |
| +3 | K221244 | CD Horizon™ Spinal System | Medtronic | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 2 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 11 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 22 | 0 |
| 2005 | 15 | 0 |
| 2006 | 9 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 8 | 0 |
| 2026 | 16 | 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? (6)
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 |
|---|---|---|---|
| * | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetSummary page 6…system 888.3070 Class II II. Predicate Devices: Primary Predicate: Medtronic HV-R™ Bone Cement (K152604, S.E. 01/06/2016) K191148 - Page 2 o… | 2016 |
| * | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Summary page 7…=== K191148 - Page 2 of 5 Additional Predicates: CD Horizon™ Spinal System (K170679, S.E. 05/11/2017) CD Horizon™ Fenestrated Screw Set (K171938, S.E. 10/23/2017) CD Horizon™ Fenestrated Screw Set… | 2017 |
| * | K171938 | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetSummary page 7…K191148 - Page 2 of 5 Additional Predicates: CD Horizon™ Spinal System (K170679, S.E. 05/11/2017) CD Horizon™ Fenestrated Screw Set (K171938, S.E. 10/23/2017) CD Horizon™ Fenestrated Screw Set (K170347, S.E. 04/04/2017) Kyphon™ HV-R™ Bone Cement (K180700,… | 2017 |
| * | K170347 | CD HORIZON™ Fenestrated Screw SetSummary page 7…CD Horizon™ Spinal System (K170679, S.E. 05/11/2017) CD Horizon™ Fenestrated Screw Set (K171938, S.E. 10/23/2017) CD Horizon™ Fenestrated Screw Set (K170347, S.E. 04/04/2017) Kyphon™ HV-R™ Bone Cement (K180700, S.E. 05/18/2018) Kyphon™ Xpede™ Bone Cement (K163032, S.E. 02… | 2017 |
| * | K180700 | KYPHON HV-R Bone CementSummary page 7…CD Horizon™ Fenestrated Screw Set (K171938, S.E. 10/23/2017) CD Horizon™ Fenestrated Screw Set (K170347, S.E. 04/04/2017) Kyphon™ HV-R™ Bone Cement (K180700, S.E. 05/18/2018) Kyphon™ Xpede™ Bone Cement (K163032, S.E. 02/27/2017) These predicate devices have not been sub… | 2018 |
| * | K163032 | Kyphon Xpede Bone CementSummary page 7…2017) CD Horizon™ Fenestrated Screw Set (K170347, S.E. 04/04/2017) Kyphon™ HV-R™ Bone Cement (K180700, S.E. 05/18/2018) Kyphon™ Xpede™ Bone Cement (K163032, S.E. 02/27/2017) These predicate devices have not been subject to a design-related recall. III. Device Description:… | 2017 |
What descends from it? (50)
See all 505 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193011 | CD Horizon™ Fenestrated Screw Set | 2020 | 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 |
| K220131 | KYPHON VuE Bone Cement | 2022 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 27 of the 174 ancestors have a recall of any class.
- Of its descendants, K193011 (Medtronic Sofamor Danek USA, Inc., 2020) has gone furthest, with 41 descendants of its own.
- 12 other devices also cite its predicate K152604.
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 without cement, CD Horizon™ Fenestrated Screws (with or without Sextant™ or Longitude™ instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tumor and/or trauma (i.e. fracture or dislocation), spinal…
Read the full statement (444 words)
When used without cement, CD Horizon™ Fenestrated Screws (with or without Sextant™ or Longitude™ instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tumor and/or trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion.
When used in conjunction with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Kyphon™ Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.
When used in conjunction with CD Horizon™ Fenestrated Screws, Kyphon™ Xpede™ Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Kyphon™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
When used in conjunction with CD Horizon™ Fenestrated Screws, Medtronic 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 in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Medtronic HV-R™ Fenestrated Screw 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/K191148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191148: Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191148
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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