510(k) · Cleared
ClearedKyphon HV-R Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · NDN Cement, Bone, Vertebroplasty
Cleared on Aug 24, 2016 as substantially equivalent to K150460 (Medtronic Sofamor Danck USA, Inc., 2015) and 1 other predicate after a 139-day review. Its family tree reaches back 7 generations to 2001. 52 later devices descend from it.
- Decided
- Aug 24, 2016
- Review
- 139 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K002652 (2001). 10 ancestors in all. 52 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 6 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- 5 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
- 4 generations backK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
- 3 generations backK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · Recalled
- 2 generations backK102397 Kyphon Xpede Bone CementMedtronic · 2011
- 1 generation backK150460 KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 2015
- This deviceK160983 Kyphon HV-R Bone CementMedtronic, Inc. · 2016
- Descendant · cites it directly · 51 of its ownK180700 KYPHON HV-R Bone CementMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · 2 generations on · 50 of its ownK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 3 generations on · 41 of its ownK193011 CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020
- Descendant · 2 generations on · 38 of its ownK201362 CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System…Medtronic · 2020
- Descendant · 3 generations on · 34 of its ownK210637 CD Horizon™ Spinal SystemMedtronic · 2021
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K180700KYPHON HV-R Bone CementMedtronic Sofamor Danek USA, Inc. · 2018 · cites it directly51descendants
- K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2019 · 2 generations on50descendants
- K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020 · 3 generations on41descendants
- K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic · 2020 · 2 generations on38descendants
- K210637CD Horizon™ Spinal SystemMedtronic · 2021 · 3 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −6 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −5 | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −4 | K042691 | Vertefix Vertebroplasty Procedure Set | Cook, Inc. | 2005 | — |
| −3 | K060300 | Confidence High Viscosity Bone Cement | Disc-O-Tech Medical Technologies, Ltd. | 2006 | 8 |
| −2 | K102397 | Kyphon Xpede Bone Cement | Medtronic | 2011 | — |
| −1 | K150460 | KYPHON (R) HV-R (R) Bone Cement | Medtronic Sofamor Danck USA, Inc. | 2015 | — |
| 0 (this device) | K160983 | Kyphon HV-R Bone Cement | Medtronic, Inc. | 2016 | — |
| +1 | K180700 | KYPHON HV-R Bone Cement | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +2 | K191148 | Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +3 | K193011 | CD Horizon™ Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
| +2 | K201362 | CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™… | Medtronic | 2020 | — |
| +3 | K210637 | CD Horizon™ Spinal System | Medtronic | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 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 NDN? 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 NDN device
- #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 4…ice Polymethylmethacrylate (PMMA) bone cement Product Classification Code NDN Predicate Devices KYPHON® HV-R® Bone Cement K150460, S.E. 04/28/2015 (Primary Predicate) KYPHON® Xpede™ Bone Cement K151… | 2015 |
| * | K151227 | KYPHON XPEDE Bone CementSummary page 4…Cement K150460, S.E. 04/28/2015 (Primary Predicate) KYPHON® Xpede™ Bone Cement K151227, S.E. 11/16/2015 The predicate devices have not been subject to a design related recall. Descripti… | 2015 |
What descends from it? (52)
See all 521 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180700 | KYPHON HV-R Bone Cement | 2018 | 51 |
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 7 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K180700 (Medtronic Sofamor Danek USA, Inc., 2018) has gone furthest, with 51 descendants of its own.
- 1 other device also cites its predicate K150460.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NDN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDN
90in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDN
4in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDN
626in 2025
MAUDE reports naming product code NDN, 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 | 9 | 128 | 0 | 21 |
| 2008 | 1 | — | 0 | 39 |
| 2009 | 6 | 211 | 1 | 70 |
| 2010 | 5 | 215 | 0 | 396 |
| 2011 | 11 | 164 | 0 | 98 |
| 2012 | 7 | 90 | 0 | 89 |
| 2013 | 7 | 118 | 4 | 242 |
| 2014 | 7 | 106 | 0 | 231 |
| 2015 | 6 | 76 | 0 | 204 |
| 2016 | 4 | 154 | 0 | 182 |
| 2017 | 5 | 125 | 0 | 191 |
| 2018 | 3 | 111 | 0 | 144 |
| 2019 | 2 | — | 0 | 227 |
| 2020 | 4 | 157 | 0 | 212 |
| 2021 | 2 | — | 0 | 344 |
| 2022 | 2 | — | 0 | 270 |
| 2023 | 2 | — | 0 | 311 |
| 2024 | 3 | 90 | 0 | 454 |
| 2025 | 2 | — | 0 | 626 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Kyphon® HV-R® 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. 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. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.
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/K160983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160983: Kyphon HV-R 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/K160983
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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