510(k) · Cleared
ClearedStaxxsd 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 Jul 19, 2011 as substantially equivalent to K052670 (Spine Wave, Inc., 2006) and 2 other predicates after a 53-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- Jul 19, 2011
- Review
- 53 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K003155 (2001). 31 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 10 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 6 generations between
- 3 generations backK052670 Staxx XD SystemSpine Wave, Inc. · 2006
- 2 generations backK090315 Staxx XD SystemSpine Wave, Inc. · 2009
- 1 generation backK101288 Staxx XD SystemSpine Wave, Inc. · 2010 · Recalled
- This deviceK111469 Staxxsd SystemSpine Wave, Inc. · 2011
Show all 10 generations
- Root · 10 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations backK012254 VBROsteotech, Inc. · 2001
- 8 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 7 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 6 generations backK030736 Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek · 2003
- 5 generations backK041452 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK043566 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2005
- 3 generations backK052670 Staxx XD SystemSpine Wave, Inc. · 2006
- 2 generations backK090315 Staxx XD SystemSpine Wave, Inc. · 2009
- 1 generation backK101288 Staxx XD SystemSpine Wave, Inc. · 2010 · Recalled
- This deviceK111469 Staxxsd SystemSpine Wave, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −9 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −8 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −7 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −6 | K030736 | Verte-Stack Spinal System, Extra Small Sizes | Medtronic Sofamor Danek | 2003 | — |
| −5 | K041452 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K043566 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −3 | K052670 | Staxx XD System | Spine Wave, Inc. | 2006 | — |
| −2 | K090315 | Staxx XD System | Spine Wave, Inc. | 2009 | — |
| −1 | K101288 | Staxx XD System | Spine Wave, Inc. | 2010 | 1 |
| 0 (this device) | 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 |
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? (4)
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 |
|---|---|---|---|
| * | K052670 | Staxx XD SystemSummary page 1…the following 51 0(k)s: Predicate Device Manufacturer 510(k) No. StaXx®O XD System Spine Wave, Inc. K052670 StaXx®@ XD System Spine Wave, Inc. K090315 StaXx IXD System Spine Wave… | 2006 |
| * | K090315 | Staxx XD SystemSummary page 1…rer 510(k) No. StaXx®O XD System Spine Wave, Inc. K052670 StaXx®@ XD System Spine Wave, Inc. K090315 StaXx IXD System Spine Wave, Inc. K101288 StaXx® XD System Spine Wave… | 2009 |
| * | K101288 | Staxx XD SystemSummary page 1…ave, Inc. K052670 StaXx®@ XD System Spine Wave, Inc. K090315 StaXx IXD System Spine Wave, Inc. K101288 StaXx® XD System Spine Wave, Inc. K128… | 2010 |
| * | — | StaXx® XD System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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 3 companies; a new generation was cleared every 10 months on median.
- 3 of the 31 ancestors have a recall of any class.
- 4 other devices also cite its predicate K052670.
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. 2011, 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 (T1-L5) 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 RXD System is the CapSure PS Spine System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111469 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111469: Staxxsd System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111469
Report an extraction error
Are you the manufacturer?
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