510(k) · Cleared
Recalled · 2009Kyphx HV-R Bone Cement, Model C01A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kyphon, Inc. · NDN Cement, Bone, Vertebroplasty
Cleared on Jul 7, 2004 as substantially equivalent to K033801 (Kyphon, Inc., 2004) and 2 other predicates after a 23-day review. Its family tree reaches back 2 generations to 2001. 209 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 7, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- NDN
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002652 (2001). 3 ancestors in all. 209 later devices descend from it, 10 citing it directly.
- Root · 2 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 1 generation backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- This deviceK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004
- Descendant · cites it directly · 189 of its ownK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
- Descendant · cites it directly · 176 of its ownK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · Recalled
- Descendant · cites it directly · 167 of its ownK093828 Kyph X HV-R Bone CementMedtronic, Inc. · 2010
- Descendant · cites it directly · 165 of its ownK102397 Kyphon Xpede Bone CementMedtronic · 2011
- Descendant · 2 generations on · 162 of its ownK150460 KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 2015
Showing 5 of 209 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 209 · See all- K042691Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005 · cites it directly189descendants
- K060300Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · cites it directly176descendants
- K093828Kyph X HV-R Bone CementMedtronic, Inc. · 2010 · cites it directly167descendants
- K102397Kyphon Xpede Bone CementMedtronic · 2011 · cites it directly165descendants
- K150460KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 2015 · 2 generations on162descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −1 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| 0 (this device) | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | — |
| +1 | K042691 | Vertefix Vertebroplasty Procedure Set | Cook, Inc. | 2005 | — |
| +1 | K060300 | Confidence High Viscosity Bone Cement | Disc-O-Tech Medical Technologies, Ltd. | 2006 | 8 |
| +1 | K093828 | Kyph X HV-R Bone Cement | Medtronic, Inc. | 2010 | — |
| +1 | K102397 | Kyphon Xpede Bone Cement | Medtronic | 2011 | — |
| +2 | K150460 | KYPHON (R) HV-R (R) Bone Cement | Medtronic Sofamor Danck USA, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 7 | 0 |
| 2007 | 10 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 9 | 0 |
| 2019 | 8 | 0 |
| 2020 | 16 | 0 |
| 2021 | 15 | 0 |
| 2022 | 16 | 0 |
| 2023 | 26 | 0 |
| 2024 | 24 | 0 |
| 2025 | 21 | 0 |
| 2026 | 28 | 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? (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 |
|---|---|---|---|
| * | K033801 | Kyphx HV-R, Model C01ASummary page 1…man Avenue Sunnyvale, CA 94089 Telephone: 408-222-6740 Predicate Device(s): K033801: KyphX® HV-RTM, Model C01A K002652: Stryker Howmedica Surgical Simplex®CP… | 2004 |
| * | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiSummary page 1…Telephone: 408-222-6740 Predicate Device(s): K033801: KyphX® HV-RTM, Model C01A K002652: Stryker Howmedica Surgical Simplex®CP Radiopaque pre-packed in ACM and MixEvac II.… | 2001 |
| * | K032945 | Simplex XSummary page 1…52: Stryker Howmedica Surgical Simplex®CP Radiopaque pre-packed in ACM and MixEvac II. K032945: Stryker Spineplex TM Radiopaque Bone Cement Intended Use: KyphX® HV-RTM bone cement is indicated for… | 2004 |
What descends from it? (209)
See all 20910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042691 | Vertefix Vertebroplasty Procedure Set | 2005 | 189 |
| K060300 | Confidence High Viscosity Bone Cement | 2006 | 176 |
| K093828 | Kyph X HV-R Bone Cement | 2010 | 167 |
| K102397 | Kyphon Xpede Bone Cement | 2011 | 165 |
| K042415 | Mendec Spine | 2005 | 28 |
| K043593 | Spine-Fix Biomimetic Bone Cement | 2006 | 22 |
| K053336 | Staxx FX System | 2006 | 12 |
| K132817 | Kiva VCF Treatment System | 2014 | 9 |
| K043406 | Vertebroplastic Radiopaque Bone Cement | 2005 | 3 |
| K192403 | VK100 Percutaneous Vertebral Augmentation System | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 10, 2009 | Not classified | Z-1625-2011 | Other | Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period. |
| Nov 10, 2009 | Not classified | Z-1624-2011 | Other | Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K042691 (Cook, Inc., 2005) has gone furthest, with 189 descendants of its own.
- 5 other devices also cite its predicate K033801.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
KyphX 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 balloon kyphoplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemagioma and giant cell tumor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041584: Kyphx HV-R Bone Cement, Model C01A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041584
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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