510(k) · Cleared
ClearedKyphon Xpede Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic · NDN Cement, Bone, Vertebroplasty
Cleared on Feb 28, 2011 as substantially equivalent to K093828 (Medtronic, Inc., 2010) and 3 other predicates after a 188-day review. Its family tree reaches back 5 generations to 2001. 165 later devices descend from it.
- Decided
- Feb 28, 2011
- Review
- 188 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K002652 (2001). 7 ancestors in all. 165 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 4 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- 3 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
- 2 generations backK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
- 1 generation backK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · Recalled
- This deviceK102397 Kyphon Xpede Bone CementMedtronic · 2011
- Descendant · cites it directly · 162 of its ownK150460 KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 2015
- Descendant · 2 generations on · 159 of its ownK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- Descendant · 3 generations on · 106 of its ownK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
- Descendant · 3 generations on · 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
Showing 5 of 165 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 165 · See all- K150460KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 2015 · cites it directly162descendants
- K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016 · 2 generations on159descendants
- K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl · 2016 · 3 generations on106descendants
- K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017 · 3 generations on91descendants
- K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic · 2017 · cites it directly64descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −4 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −3 | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −2 | K042691 | Vertefix Vertebroplasty Procedure Set | Cook, Inc. | 2005 | — |
| −1 | K060300 | Confidence High Viscosity Bone Cement | Disc-O-Tech Medical Technologies, Ltd. | 2006 | 8 |
| 0 (this device) | K102397 | Kyphon Xpede Bone Cement | Medtronic | 2011 | — |
| +1 | K150460 | KYPHON (R) HV-R (R) Bone Cement | Medtronic Sofamor Danck USA, Inc. | 2015 | — |
| +2 | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | 2016 | — |
| +3 | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated… | Medos International Sàrl | 2016 | — |
| +3 | K170347 | CD HORIZON™ Fenestrated Screw Set | Medtronic Sofamor Danek USA | 2017 | — |
| +1 | K171938 | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set | Medtronic | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 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 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? (4)
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 |
|---|---|---|---|
| * | K093828 | Kyph X HV-R Bone Cement Our OCR of the scanned summary read K093829, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “KyphX HV-R® Bone Cement”. | 2010 |
| * | K041584 | Kyphx HV-R Bone Cement, Model C01ASummary page 1…nts of the Food Drug and Cosmetic Act, under section 514 for performance standards, are not applicable to the KyphX HV-R® Bone Cement. K 093829 KyphX HV- R® Bone Cement K041584 KyphX HV- R® Bone Cement K033801 KyphX HV-R® Bone Cement K060300 Confidence High Viscosity Bone Cement KYPHON® Xpede™ Bone Cemen… | 2004 |
| * | K033801 | Kyphx HV-R, Model C01ASummary page 1…Act, under section 514 for performance standards, are not applicable to the KyphX HV-R® Bone Cement. K 093829 KyphX HV- R® Bone Cement K041584 KyphX HV- R® Bone Cement K033801 KyphX HV-R® Bone Cement K060300 Confidence High Viscosity Bone Cement KYPHON® Xpede™ Bone Cement is indicated for the treatment… | 2004 |
| * | K060300 | Confidence High Viscosity Bone CementSummary page 1…ormance standards, are not applicable to the KyphX HV-R® Bone Cement. K 093829 KyphX HV- R® Bone Cement K041584 KyphX HV- R® Bone Cement K033801 KyphX HV-R® Bone Cement K060300 Confidence High Viscosity Bone Cement KYPHON® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the… | 2006 |
What descends from it? (165)
See all 1654 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K150460 (Medtronic Sofamor Danck USA, Inc., 2015) has gone furthest, with 162 descendants of its own.
- 2 other devices also cite its predicate K093828.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a 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.
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/K102397 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102397: Kyphon Xpede Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102397
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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