510(k) · Cleared
ClearedModification to Staxx FX System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · OBL Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
Cleared on Apr 13, 2007 as substantially equivalent to K053336 (Spine Wave, Inc., 2006) after a 133-day review. Its family tree reaches back 9 generations to 1997. 11 later devices descend from it.
- Decided
- Apr 13, 2007
- Review
- 133 days
- Class
- Class II
- Product code
- OBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K970097 (1997). 39 ancestors in all, the oldest K803106 (1981). 11 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 5 generations between
- 3 generations backK034037 Sky Bone Expander SystemDisc-O-Tech Medical Technologies, Ltd. · 2004
- 2 generations backK040612 Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd. · 2004
- 1 generation backK053336 Staxx FX SystemSpine Wave, Inc. · 2006
- This deviceK063606 Modification to Staxx FX SystemSpine Wave, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK181262 SpineJack Expansion KitVexim SA · 2018
- Descendant · 3 generations on · 3 of its ownK202393 SpineJack Expansion KitStryker Corporation · 2020
- Descendant · 4 generations on · 2 of its ownK211238 SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex…Stryker Instruments · 2021
- Descendant · 2 generations on · 2 of its ownK191709 V-STRUT Vertebral ImplantHyprevention Sas · 2020
Show all 9 generations
- Root · 9 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 8 generations backK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 7 generations backK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 6 generations backK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
- 5 generations backK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
- 4 generations backK032358 B-Twin Bone Expander System (B-Twin BE System)Disc-O-Tech Medical Technologies, Ltd. · 2003
- 3 generations backK034037 Sky Bone Expander SystemDisc-O-Tech Medical Technologies, Ltd. · 2004
- 2 generations backK040612 Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd. · 2004
- 1 generation backK053336 Staxx FX SystemSpine Wave, Inc. · 2006
- This deviceK063606 Modification to Staxx FX SystemSpine Wave, Inc. · 2007
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014 · cites it directly9descendants
- K181262SpineJack Expansion KitVexim SA · 2018 · 2 generations on4descendants
- K202393SpineJack Expansion KitStryker Corporation · 2020 · 3 generations on3descendants
- K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments · 2021 · 4 generations on2descendants
- K191709V-STRUT Vertebral ImplantHyprevention Sas · 2020 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −8 | K010988 | Fixion Interlocking Proximal Femoral Nailing System | Disc-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −7 | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing… | Disco-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −6 | K021324 | Fixion Intramedullary Nailing System (Fixion IM Nailing System) | Disco-O-Tech Medical Technologies, Ltd. | 2002 | 1 |
| −5 | K023437 | Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF… | Disco-O-Tech Medical Technologies, Ltd. | 2002 | — |
| −4 | K032358 | B-Twin Bone Expander System (B-Twin BE System) | Disc-O-Tech Medical Technologies, Ltd. | 2003 | — |
| −3 | K034037 | Sky Bone Expander System | Disc-O-Tech Medical Technologies, Ltd. | 2004 | — |
| −2 | K040612 | Sky Bone Expander System (Sky System) | Disc-O-Tech Medical Technologies, Ltd. | 2004 | — |
| −1 | K053336 | Staxx FX System | Spine Wave, Inc. | 2006 | — |
| 0 (this device) | K063606 | Modification to Staxx FX System | Spine Wave, Inc. | 2007 | — |
| +1 | K132817 | Kiva VCF Treatment System | Benvenue Medical, Inc. | 2014 | — |
| +2 | K181262 | SpineJack Expansion Kit | Vexim SA | 2018 | — |
| +3 | K202393 | SpineJack Expansion Kit | Stryker Corporation | 2020 | — |
| +4 | K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV… | Stryker Instruments | 2021 | — |
| +2 | K191709 | V-STRUT Vertebral Implant | Hyprevention Sas | 2020 | — |
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 |
|---|---|---|
| 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 OBL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K053336 | Staxx FX SystemSummary page 2…Manufacturer 510(k) No. StaXxTM PX System Spine Wave, Inc. K (053336 In addition, mechanical testing demonstrated that the StaXxTM FX System meets the performance requirements f… | 2006 |
What descends from it? (11)
See all 112 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 4 companies; a new generation was cleared every 8 months on median.
- 12 of the 39 ancestors have a recall of any class.
- Of its descendants, K132817 (Benvenue Medical, Inc., 2014) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K053336.
How does its category compare?
All OBL devicesOBL Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OBL
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · OBL
Too few OBL 510(k)s in any year since 2007 to give a median.
Recalls per year · OBL
No recall names OBL since 2007.
Adverse event reports per year · OBL
1in 2022
MAUDE reports naming product code OBL, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The StaXxTM FX System is indicated for use in the reduction of spinal fractures. It is intended to be used in combination with Stryker SpineplexTM Radiopaque Bone Cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063606: Modification to Staxx FX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063606
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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