510(k) · Cleared
ClearedStaxx FX System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · NDN Cement, Bone, Vertebroplasty
Cleared on Jul 3, 2006 as substantially equivalent to K041454 (Kyphon, Inc., 2004) and 4 other predicates after a 214-day review. Its family tree reaches back 8 generations to 1997. 12 later devices descend from it.
- Decided
- Jul 3, 2006
- Review
- 214 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K970097 (1997). 38 ancestors in all, the oldest K803106 (1981). 12 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 7 generations backK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 6 generations backK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 5 generations backK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
- 4 generations backK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
- 3 generations backK032358 B-Twin Bone Expander System (B-Twin BE System)Disc-O-Tech Medical Technologies, Ltd. · 2003
- 2 generations backK034037 Sky Bone Expander SystemDisc-O-Tech Medical Technologies, Ltd. · 2004
- 1 generation backK040612 Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd. · 2004
- This deviceK053336 Staxx FX SystemSpine Wave, Inc. · 2006
- Descendant · cites it directly · 11 of its ownK063606 Modification to Staxx FX SystemSpine Wave, Inc. · 2007
- Descendant · 2 generations on · 9 of its ownK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
- Descendant · 3 generations on · 4 of its ownK181262 SpineJack Expansion KitVexim SA · 2018
- Descendant · 4 generations on · 3 of its ownK202393 SpineJack Expansion KitStryker Corporation · 2020
- Descendant · 5 generations on · 2 of its ownK211238 SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex…Stryker Instruments · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K063606Modification to Staxx FX SystemSpine Wave, Inc. · 2007 · cites it directly11descendants
- K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014 · 2 generations on9descendants
- K181262SpineJack Expansion KitVexim SA · 2018 · 3 generations on4descendants
- K202393SpineJack Expansion KitStryker Corporation · 2020 · 4 generations on3descendants
- K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments · 2021 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −7 | K010988 | Fixion Interlocking Proximal Femoral Nailing System | Disc-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −6 | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing… | Disco-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −5 | K021324 | Fixion Intramedullary Nailing System (Fixion IM Nailing System) | Disco-O-Tech Medical Technologies, Ltd. | 2002 | 1 |
| −4 | K023437 | Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF… | Disco-O-Tech Medical Technologies, Ltd. | 2002 | — |
| −3 | K032358 | B-Twin Bone Expander System (B-Twin BE System) | Disc-O-Tech Medical Technologies, Ltd. | 2003 | — |
| −2 | K034037 | Sky Bone Expander System | Disc-O-Tech Medical Technologies, Ltd. | 2004 | — |
| −1 | K040612 | Sky Bone Expander System (Sky System) | Disc-O-Tech Medical Technologies, Ltd. | 2004 | — |
| 0 (this device) | K053336 | Staxx FX System | Spine Wave, Inc. | 2006 | — |
| +1 | K063606 | Modification to Staxx FX System | Spine Wave, Inc. | 2007 | — |
| +2 | K132817 | Kiva VCF Treatment System | Benvenue Medical, Inc. | 2014 | — |
| +3 | K181262 | SpineJack Expansion Kit | Vexim SA | 2018 | — |
| +4 | K202393 | SpineJack Expansion Kit | Stryker Corporation | 2020 | — |
| +5 | K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV… | Stryker Instruments | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (5)
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 |
|---|---|---|---|
| * | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13ASummary page 2…owing devices: Predicate Device Manufacturer 510(k) No. Kyp X® Xpander Inflatable Bone Tamps Kyphon, Inc. K041454 SKyBone Expander System Disc-O-Tech, Ltd. K040612 KyphX® HV-R T M Bone Cement… | 2004 |
| * | K040612 | Sky Bone Expander System (Sky System)Summary page 2…510(k) No. Kyp X® Xpander Inflatable Bone Tamps Kyphon, Inc. K041454 SKyBone Expander System Disc-O-Tech, Ltd. K040612 KyphX® HV-R T M Bone Cement Kybhon, Inc. K041584 Stryker SpineplexTM Radiopaque Bone Cement… | 2004 |
| * | K041584 | Kyphx HV-R Bone Cement, Model C01ASummary page 2…K041454 SKyBone Expander System Disc-O-Tech, Ltd. K040612 KyphX® HV-R T M Bone Cement Kybhon, Inc. K041584 Stryker SpineplexTM Radiopaque Bone Cement Styker Corporation K032945 The Wafer System… | 2004 |
| * | K032945 | Simplex XSummary page 2…Ltd. K040612 KyphX® HV-R T M Bone Cement Kybhon, Inc. K041584 Stryker SpineplexTM Radiopaque Bone Cement Styker Corporation K032945 The Wafer System Spi Wave, ne Inc. K033303 In addition, mechanical testing demonstrated t… | 2004 |
| * | K033303 | Wafer SystemSummary page 2…K041584 Stryker SpineplexTM Radiopaque Bone Cement Styker Corporation K032945 The Wafer System Spi Wave, ne Inc. K033303 In addition, mechanical testing demonstrated that the StaXxTM FX System meets the performance requirements for its intended… | 2004 |
What descends from it? (12)
See all 122 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 9 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 12 of the 38 ancestors have a recall of any class.
- Of its descendants, K063606 (Spine Wave, Inc., 2007) has gone furthest, with 11 descendants of its own.
- 22 other devices also cite its predicate K041454.
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?
The StaXx FX System is indicated for use in the reduction of spinal fractures. It is intended to be used in combination with Stryker Spineplex Radiopaque Bone Cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053336 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053336: Staxx FX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053336
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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