510(k) Report

510(k) · Cleared

Cleared

Staxx XD System

K052670510(k) TraditionalCleared Apr 27, 2006212-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spine Wave, Inc. · MQP Spinal Vertebral Body Replacement Device

Cleared on Apr 27, 2006 as substantially equivalent to K043566 (Medtronic Sofamor Danek, 2005) and 5 other predicates after a 212-day review. Its family tree reaches back 7 generations to 2001. 8 later devices descend from it.

Decided
Apr 27, 2006
Review
212 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
6

Its longest line of descent runs back 7 generations to K003155 (2001). 28 ancestors in all, the oldest K841189 (1984). 8 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 4 other ancestors2003: 6 other ancestors2002: 2 other ancestors1998: 1 other ancestor2001: 5 other ancestors2000: 1 other ancestor1999: 1 other ancestor1984: 1 other ancestor2011: 2 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2014: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030736 (2003) K041452 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K043566 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 200519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 5 other ancestors3 generations back: 8 other ancestors4 generations back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K043566 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2005K041452 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030736 · Verte-Stack Spinal System, Extra Small Sizes · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−50
  1. Root · 7 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 6 generations backK012254 VBROsteotech, Inc. · 2001
  3. 5 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 4 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 3 generations backK030736 Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek · 2003
  6. 2 generations backK041452 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 1 generation backK043566 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2005
  8. This deviceK052670 Staxx XD SystemSpine Wave, Inc. · 2006
  9. Descendant · cites it directly · 6 of its ownK090315 Staxx XD SystemSpine Wave, Inc. · 2009
  10. Descendant · 2 generations on · 5 of its ownK101288 Staxx XD SystemSpine Wave, Inc. · 2010 · Recalled
  11. Descendant · cites it directly · 3 of its ownK102315 Staxx XDL SystemSpine Wave, Inc. · 2011
  12. Descendant · 2 generations on · 1 of its ownK133207 Staxx (R) SystemSpine Wave, Inc. · 2013
  13. Descendant · 3 generations on · 0 of its ownK142996 StaXx (R) XD SystemSpine Wave, Inc. · 2015

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 12011: 22013: 12014: 12015: 1
2008high 2 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 8 · See all
  • K090315Staxx XD SystemSpine Wave, Inc. · 2009 · cites it directly6descendants
  • K101288Staxx XD SystemSpine Wave, Inc. · 2010 · 2 generations on5descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−6K012254VBROsteotech, Inc.2001—
−5K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−4K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−3K030736Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek2003—
−2K041452Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−1K043566Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005—
0 (this device)K052670Staxx XD SystemSpine Wave, Inc.2006—
+1K090315Staxx XD SystemSpine Wave, Inc.2009—
+2K101288Staxx XD SystemSpine Wave, Inc.20101
+1K102315Staxx XDL SystemSpine Wave, Inc.2011—
+2K133207Staxx (R) SystemSpine Wave, Inc.2013—
+3K142996StaXx (R) XD SystemSpine Wave, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199810
199910
200010
200150
200220
200360
200440

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201010
201120
201310
201410
201510
FIG. 1 — Lineage of K052670, 2001–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K043566Modification to Verte-Stack Spinal System
Summary page 1
…Substantial equivalence The StaXXTM XD System was demonstrated to be substantially equivalent to the VERTE-STACK~m Spinal System (Medtronic Sofamor Danek; K043566), the BlackstoneTM PEEK VBR System (Blackstone Medical, Inc., K041939 and K033702), the PEEK TetrisTm System (SIGNU…
Medtronic Sofamor Danek2005—
*K041939Blackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers
Summary page 1
…substantially equivalent to the VERTE-STACK~m Spinal System (Medtronic Sofamor Danek; K043566), the BlackstoneTM PEEK VBR System (Blackstone Medical, Inc., K041939 and K033702), the PEEK TetrisTm System (SIGNUS Medical LLC, K03 1757), the Sustain Radiolucent Spacer (Globus Medic…
Blackstone Medical, Inc.2004—
*K033702Blackstone Peek Vertebral Body Replacement System
Summary page 1
…alent to the VERTE-STACK~m Spinal System (Medtronic Sofamor Danek; K043566), the BlackstoneTM PEEK VBR System (Blackstone Medical, Inc., K041939 and K033702), the PEEK TetrisTm System (SIGNUS Medical LLC, K03 1757), the Sustain Radiolucent Spacer (Globus Medical Inc., K040284) a…
Blackstone Medical, Inc.2004—
*K031757Peek Tetris Spinal Implant
Summary page 1
…ic Sofamor Danek; K043566), the BlackstoneTM PEEK VBR System (Blackstone Medical, Inc., K041939 and K033702), the PEEK TetrisTm System (SIGNUS Medical LLC, K03 1757), the Sustain Radiolucent Spacer (Globus Medical Inc., K040284) and The Wafer System (Spine Wave, K033303). In addi…
Signus Medical, LLC2003—
*K040284Sustain Radiolucent Spacer
Summary page 1
…ackstone Medical, Inc., K041939 and K033702), the PEEK TetrisTm System (SIGNUS Medical LLC, K03 1757), the Sustain Radiolucent Spacer (Globus Medical Inc., K040284) and The Wafer System (Spine Wave, K033303). In addition, mechanical testing demonstrated Two Enterprise Drive -…
Globus Medical, Inc.2004—
*K033303Wafer System
Summary page 1
…), the PEEK TetrisTm System (SIGNUS Medical LLC, K03 1757), the Sustain Radiolucent Spacer (Globus Medical Inc., K040284) and The Wafer System (Spine Wave, K033303). In addition, mechanical testing demonstrated Two Enterprise Drive -Suite 302 * Shelton, CT 06484 -Tel: 203-944-9494 -…
Spine Wave, Inc.2004—

Also cleared against K043566: 1 other device →

What descends from it? (8)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090315Staxx XD SystemSpine Wave, Inc.20096
K102315Staxx XDL SystemSpine Wave, Inc.20113
K140563Lateral VBR SystemNu Vasive, Incorporated20140
K111469Staxxsd SystemSpine Wave, Inc.20110
K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine20080

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 5 years and passes through 3 companies; a new generation was cleared every 9 months on median.
  • 2 of the 28 ancestors have a recall of any class.
  • Of its descendants, K090315 (Spine Wave, Inc., 2009) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K043566.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The StaXxTM 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 bone graft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXxTM XD System is the Stryker Xia® Spinal System.

Indications for use as stated in the FDA summary.

Also cleared against K043566

1 other device cites the same predicate.

  • K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek · 2008

More from Spine Wave, Inc.

59 FDA decisions under this applicant name. See the company

  • K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc. · 2026
  • K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc. · 2026
  • K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc. · 2025
  • K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc. · 2025
  • K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc. · 2025

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K052670 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052670: Staxx XD System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052670

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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