510(k) · Cleared
Recalled · Class II · 2017Simplex X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · LOD Bone Cement
Cleared on May 25, 2004 after a 246-day review. The FDA summary names its predicate without a number. 248 later devices descend from it. It has been recalled 2 times.
- Decided
- May 25, 2004
- Review
- 246 days
- Class
- Class II
- Product code
- LOD
- Recalls
- 2
- Predicates
- 0
248 later devices descend from it, 15 citing it directly.
- This deviceK032945 Simplex XStryker Corp. · 2004
- Descendant · cites it directly · 209 of its ownK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
- 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 · 2 generations on · 167 of its ownK093828 Kyph X HV-R Bone CementMedtronic, Inc. · 2010
- Descendant · 2 generations on · 165 of its ownK102397 Kyphon Xpede Bone CementMedtronic · 2011
Showing 5 of 248 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 248 · See all- K041584Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · cites it directly209descendants
- 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 · 2 generations on167descendants
- K102397Kyphon Xpede Bone CementMedtronic · 2011 · 2 generations on165descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032945 | Simplex X | Stryker Corp. | 2004 | — |
| +1 | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | 2 |
| +1 | K042691 | Vertefix Vertebroplasty Procedure Set | Cook, Inc. | 2005 | — |
| +1 | K060300 | Confidence High Viscosity Bone Cement | Disc-O-Tech Medical Technologies, Ltd. | 2006 | 8 |
| +2 | K093828 | Kyph X HV-R Bone Cement | Medtronic, Inc. | 2010 | — |
| +2 | K102397 | Kyphon Xpede Bone Cement | Medtronic | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 9 | 0 |
| 2007 | 12 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 8 | 0 |
| 2018 | 10 | 0 |
| 2019 | 10 | 0 |
| 2020 | 18 | 0 |
| 2021 | 15 | 0 |
| 2022 | 16 | 0 |
| 2023 | 27 | 0 |
| 2024 | 25 | 0 |
| 2025 | 22 | 0 |
| 2026 | 29 | 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 LOD? 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 LOD device
- #1 K254107 Refobacin Bone Cement R (110034355)score 11.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Stryker Simplex® P Named without a submission number |
What descends from it? (248)
See all 24815 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041584 | Kyphx HV-R Bone Cement, Model C01A | 2004 | 209 |
| K042691 | Vertefix Vertebroplasty Procedure Set | 2005 | 189 |
| K060300 | Confidence High Viscosity Bone Cement | 2006 | 176 |
| K072118 | Stryker Vertaplex Radiopaque Bone Cement | 2007 | 63 |
| K161114 | HIGH V+ | 2017 | 42 |
| K042415 | Mendec Spine | 2005 | 28 |
| K043518 | Radiopaque Bone Cement | 2005 | 27 |
| K053336 | Staxx FX System | 2006 | 12 |
| K042168 | CONCORD Radiopaque Bone Cement | 2005 | 6 |
| K043406 | Vertebroplastic Radiopaque Bone Cement | 2005 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2017 | Class II | Z-1250-2018 | Environmental control | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
| Nov 30, 2011 | Not classified | Z-0862-2012 | Component change control | Product was packaged with a four inch needle in stead of the correct five inch needle. There is a potential that the needle may not be able to reach the fracture site, which may require additional medical intervention. In addition, if the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041584 (Kyphon, Inc., 2004) has gone furthest, with 209 descendants of its own.
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LOD
277in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOD
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOD
355in 2025
MAUDE reports naming product code LOD, 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 | 2 | — | 0 | 78 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 3 | 103 | 0 | 170 |
| 2010 | 0 | — | 0 | 291 |
| 2011 | 0 | — | 0 | 428 |
| 2012 | 0 | — | 0 | 412 |
| 2013 | 2 | — | 0 | 501 |
| 2014 | 1 | — | 1 | 465 |
| 2015 | 4 | 138 | 0 | 529 |
| 2016 | 1 | — | 0 | 615 |
| 2017 | 3 | 96 | 4 | 817 |
| 2018 | 2 | — | 0 | 1,295 |
| 2019 | 4 | 90 | 0 | 2,307 |
| 2020 | 3 | 139 | 1 | 1,294 |
| 2021 | 4 | 95 | 0 | 782 |
| 2022 | 3 | 277 | 2 | 472 |
| 2023 | 2 | — | 0 | 475 |
| 2024 | 1 | — | 0 | 492 |
| 2025 | 1 | — | 0 | 355 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
SpineplexTM Radiopaque Bone cement is indicated for the 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032945: Simplex X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032945
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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