510(k) · Cleared
ClearedStaxx (R) 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 Dec 6, 2013 as substantially equivalent to K121889 (Spine Wave, Inc., 2012) and 3 other predicates after a 49-day review. Its family tree reaches back 15 generations to 1984. 1 later device descends from it.
- Decided
- Dec 6, 2013
- Review
- 49 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K841189 (1984). 74 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK123461 Staxx (R) IB SystemSpine Wave, Inc. · 2013 · Recalled
- 2 generations backK131071 Staxx Ibl SystemSpine Wave, Inc. · 2013
- 1 generation backK132719 Staxx Ibl SystemSpine Wave, Inc. · 2013
- This deviceK133207 Staxx (R) SystemSpine Wave, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK142996 StaXx (R) XD SystemSpine Wave, Inc. · 2015
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 11 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 10 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 9 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 8 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 7 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 6 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 5 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 4 generations backK113527 Opticage Interbody Fusion DeviceInterventional Spine, Inc. · 2012
- 3 generations backK123461 Staxx (R) IB SystemSpine Wave, Inc. · 2013 · Recalled
- 2 generations backK131071 Staxx Ibl SystemSpine Wave, Inc. · 2013
- 1 generation backK132719 Staxx Ibl SystemSpine Wave, Inc. · 2013
- This deviceK133207 Staxx (R) SystemSpine Wave, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K142996StaXx (R) XD SystemSpine Wave, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −11 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −10 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −9 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −8 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −7 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −6 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −5 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| −4 | K113527 | Opticage Interbody Fusion Device | Interventional Spine, Inc. | 2012 | — |
| −3 | K123461 | Staxx (R) IB System | Spine Wave, Inc. | 2013 | 1 |
| −2 | K131071 | Staxx Ibl System | Spine Wave, Inc. | 2013 | — |
| −1 | K132719 | Staxx Ibl System | Spine Wave, Inc. | 2013 | — |
| 0 (this device) | K133207 | Staxx (R) System | Spine Wave, Inc. | 2013 | — |
| +1 | K142996 | StaXx (R) XD System | Spine Wave, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 11 | 0 |
| 2004 | 11 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K121889 | Staxx XD SystemSummary page 1…wing predicates: Predicate Device Manufacturer Mostk rcn. StaXx® XD System Spine Wave, Inc. K121889 StaXx XDL System Spine Wave, Inc. K102315 StaXxO 113 System Spin… | 2012 |
| * | K102315 | Staxx XDL SystemSummary page 1…Mostk rcn. StaXx® XD System Spine Wave, Inc. K121889 StaXx XDL System Spine Wave, Inc. K102315 StaXxO 113 System Spine Wave, Inc. K123461 StaXxO IBL System Spin… | 2011 |
| * | K123461 | Staxx (R) IB SystemSummary page 1…nc. K121889 StaXx XDL System Spine Wave, Inc. K102315 StaXxO 113 System Spine Wave, Inc. K123461 StaXxO IBL System Spine Wave, Inc. K132719… | 2013 |
| * | K132719 | Staxx Ibl SystemSummary page 1…nc. K102315 StaXxO 113 System Spine Wave, Inc. K123461 StaXxO IBL System Spine Wave, Inc. K132719 K133207… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142996 | StaXx (R) XD System | 2015 | 0 |
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 29 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 8 of the 74 ancestors have a recall of any class.
- Of its descendants, K142996 (Spine Wave, Inc., 2015) has gone furthest, with 0 descendants of its own.
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. 2013, 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?
T1e StaXx®&Systems have the following indications: The Stax XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-LS5) 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…
Read the full statement (348 words)
T1e StaXx®&Systems have the following indications:
The Stax XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-LS5) 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;
The StaXx® XDL System isa 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 used with autograft or allograft and supplemental spinal fixation.
The StaXx@8 lB System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) of the lumbar spine at one or two contiguous levels from L2-S 1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These ODD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx®I lB System is to be used wvith autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
The StaXx® IAL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) of the lumbar spine at one or two contiguous levels from L2-LS. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These ODD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133207: Staxx (R) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133207
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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