510(k) · Cleared
Recalled · 2010Staxx XD System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Sep 10, 2010 as substantially equivalent to K090315 (Spine Wave, Inc., 2009) after a 126-day review. Its family tree reaches back 9 generations to 2001. 5 later devices descend from it. It has been recalled once.
- Decided
- Sep 10, 2010
- Review
- 126 days
- Class
- Class II
- Product code
- MQP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K003155 (2001). 30 ancestors in all, the oldest K841189 (1984). 5 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 5 generations between
- 3 generations backK043566 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2005
- 2 generations backK052670 Staxx XD SystemSpine Wave, Inc. · 2006
- 1 generation backK090315 Staxx XD SystemSpine Wave, Inc. · 2009
- This deviceK101288 Staxx XD SystemSpine Wave, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK102315 Staxx XDL SystemSpine Wave, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK133207 Staxx (R) SystemSpine Wave, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK142996 StaXx (R) XD SystemSpine Wave, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK140563 Lateral VBR SystemNu Vasive, Incorporated · 2014
- Descendant · cites it directly · 0 of its ownK111469 Staxxsd SystemSpine Wave, Inc. · 2011
Show all 9 generations
- Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations backK012254 VBROsteotech, Inc. · 2001
- 7 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 6 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 5 generations backK030736 Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek · 2003
- 4 generations backK041452 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 3 generations backK043566 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2005
- 2 generations backK052670 Staxx XD SystemSpine Wave, Inc. · 2006
- 1 generation backK090315 Staxx XD SystemSpine Wave, Inc. · 2009
- This deviceK101288 Staxx XD SystemSpine Wave, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K102315Staxx XDL SystemSpine Wave, Inc. · 2011 · cites it directly3descendants
- K133207Staxx (R) SystemSpine Wave, Inc. · 2013 · 2 generations on1descendant
- K142996StaXx (R) XD SystemSpine Wave, Inc. · 2015 · 3 generations on0descendants
- K140563Lateral VBR SystemNu Vasive, Incorporated · 2014 · 2 generations on0descendants
- K111469Staxxsd SystemSpine Wave, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −8 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −7 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −6 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −5 | K030736 | Verte-Stack Spinal System, Extra Small Sizes | Medtronic Sofamor Danek | 2003 | — |
| −4 | K041452 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −3 | K043566 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −2 | K052670 | Staxx XD System | Spine Wave, Inc. | 2006 | — |
| −1 | K090315 | Staxx XD System | Spine Wave, Inc. | 2009 | — |
| 0 (this device) | K101288 | Staxx XD System | Spine Wave, Inc. | 2010 | — |
| +1 | K102315 | Staxx XDL System | Spine Wave, Inc. | 2011 | — |
| +2 | K133207 | Staxx (R) System | Spine Wave, Inc. | 2013 | — |
| +3 | K142996 | StaXx (R) XD System | Spine Wave, Inc. | 2015 | — |
| +2 | K140563 | Lateral VBR System | Nu Vasive, Incorporated | 2014 | — |
| +1 | K111469 | Staxxsd System | Spine Wave, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 MQP? 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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 |
|---|---|---|---|
| * | K090315 | Staxx XD SystemSummary page 2…ce: Predicate Device Manufacturer 510(k) No. StaXx® XD System Spine Wave, Inc. K0903 15 The mechanical testing performed on the modified StaXx®O XD System included dynamic axial compression and dynamic t… | 2009 |
What descends from it? (5)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 22, 2010 | Not classified | Z-0967-2011 | Packaging process control | Package Insert Incorrect |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 2 of the 30 ancestors have a recall of any class.
- Of its descendants, K102315 (Spine Wave, Inc., 2011) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K090315.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The StaXx® XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L-5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx® XD System is the CapSure® PS Spine System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101288 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101288: Staxx XD System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101288
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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