510(k) · Cleared
ClearedSpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · NDN Cement, Bone, Vertebroplasty
Cleared on Jun 25, 2021 as substantially equivalent to K202393 (Stryker Corporation, 2020) and 2 other predicates after a 60-day review. Its family tree reaches back 15 generations to 2004. 2 later devices descend from it.
- Decided
- Jun 25, 2021
- Review
- 60 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K040583 (2004). 180 ancestors in all, the oldest K803106 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations between
- 3 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- 2 generations backK171938 KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic · 2017
- 1 generation backK192818 Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable…Stryker Corporation · 2020
- This deviceK211238 SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex…Stryker Instruments · 2021
- Descendant · cites it directly · 1 of its ownK223294 SpineJack® Expansion KitStryker Instruments · 2022
- Descendant · 2 generations on · 0 of its ownK250637 VCFix Spinal SystemAmber Implants · 2025
Show all 15 generations
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 12 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 10 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 9 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 7 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 6 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 5 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 4 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 3 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- 2 generations backK171938 KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic · 2017
- 1 generation backK192818 Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable…Stryker Corporation · 2020
- This deviceK211238 SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex…Stryker Instruments · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −12 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −10 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −9 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −7 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −6 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −5 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −4 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −3 | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | 2016 | — |
| −2 | K171938 | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set | Medtronic | 2017 | — |
| −1 | K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal… | Stryker Corporation | 2020 | — |
| 0 (this device) | K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV… | Stryker Instruments | 2021 | — |
| +1 | K223294 | SpineJack® Expansion Kit | Stryker Instruments | 2022 | — |
| +2 | K250637 | VCFix Spinal System | Amber Implants | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 11 | 0 |
| 2001 | 17 | 0 |
| 2002 | 11 | 0 |
| 2003 | 12 | 0 |
| 2004 | 26 | 0 |
| 2005 | 16 | 0 |
| 2006 | 18 | 0 |
| 2007 | 8 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K202393 | SpineJack Expansion KitSummary page 7…K211238 II. Predicate Devices SpineJack® Expansion Kit, K202393 Vertaplex Radiopaque Bone Cement, K072118 Vertaplex High Viscosity (HV) Radiopaque Bone Cement, K192818 These predicates have not… | 2020 |
| * | K072118 | Stryker Vertaplex Radiopaque Bone CementSummary page 7…K211238 II. Predicate Devices SpineJack® Expansion Kit, K202393 Vertaplex Radiopaque Bone Cement, K072118 Vertaplex High Viscosity (HV) Radiopaque Bone Cement, K192818 These predicates have not been subject to a design-related recall,… | 2007 |
| * | K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemSummary page 7…K211238 II. Predicate Devices SpineJack® Expansion Kit, K202393 Vertaplex Radiopaque Bone Cement, K072118 Vertaplex High Viscosity (HV) Radiopaque Bone Cement, K192818 These predicates have not been subject to a design-related recall, and no reference devices were used in this submission. III.… | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223294 | SpineJack® Expansion Kit | 2022 | 1 |
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 17 years and passes through 7 companies; a new generation was cleared every 5 months on median.
- 30 of the 180 ancestors have a recall of any class.
- Of its descendants, K223294 (Stryker Instruments, 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures, and traumatic vertebral compression fractures (Type A fractures according to the AO/Magerl classification) with or without posterior instrumental fixation. They are intended to be used in combination with Stryker Vertaplex® and Vertaplex® HV bone cement. Vertaplex® Radiopaque Bone Cement is indicated for fixation of pathological…
Read the full statement (303 words)
The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures, and traumatic vertebral compression fractures (Type A fractures according to the AO/Magerl classification) with or without posterior instrumental fixation. They are intended to be used in combination with Stryker Vertaplex® and Vertaplex® HV bone cement.
Vertaplex® Radiopaque Bone Cement is indicated for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
When used in conjunction with the SpineJack Expansion Kit, Vertaplex® Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Maged Type A vertebral compression fractures.
Vertaplex® HV Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
When used in conjunction with ES2® Augmentable Spinal System, Vertaplex® High Viscosity (HV) Radiopaque Bone 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. Vertaplex® High Viscosity (HV) Radiopaque Bone Cement and the ES2® Augmentable Spinal System are for use together at spinal levels where the structural integrity of the spine is not severely compromised.
When used in conjunction with the SpineJack Expansion Kit, Vertaplex® High Viscosity (HV) Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Magerl Type A vertebral compression fractures.
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/K211238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211238: SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque 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/K211238
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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