510(k) Report

510(k) · Cleared

Cleared

Staxx XDL System

K102315510(k) TraditionalCleared Aug 19, 2011368-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 Aug 19, 2011 as substantially equivalent to K052670 (Spine Wave, Inc., 2006) and 5 other predicates after a 368-day review. Its family tree reaches back 10 generations to 2001. 3 later devices descend from it.

Decided
Aug 19, 2011
Review
368 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
6

Its longest line of descent runs back 10 generations to K003155 (2001). 57 ancestors in all, the oldest K841189 (1984). 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 1 other ancestor2006: 2 other ancestors2005: 5 other ancestors2004: 11 other ancestors2003: 12 other ancestors2002: 5 other ancestors1999: 1 other ancestor1998: 1 other ancestor2001: 6 other ancestors2000: 1 other ancestor1984: 1 other ancestor2013: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×2: 2 generations cleared close together, K021791 (2002), K023570 (2002) K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004×2: 2 generations cleared close together, K042571 (2005), K050624 (2005) K062132 · Avs PL Peek Spacer System · Stryker Spine · 2006K070218 · Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR) · Vertiflex (Tm), Incorporated · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 12 other ancestors3 generations back: 15 other ancestors4 generations back: 10 other ancestors5 generations back: 5 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K070218 · Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR) · Vertiflex (Tm), Incorporated · 2007K062132 · Avs PL Peek Spacer System · Stryker Spine · 2006K050624 · Stryker Spine Avs PL Peek Spacer · Stryker Spine · 2005K042571 · Stryker Spine Avs TL Peek Spacer · Stryker Spine · 2005K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004K031780 · Verte-Stack Spinal System · 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. · 2001−10−50
  1. Root · 10 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 6 generations between
  3. 3 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  4. 2 generations backK062132 Avs PL Peek Spacer SystemStryker Spine · 2006
  5. 1 generation backK070218 Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated · 2007
  6. This deviceK102315 Staxx XDL SystemSpine Wave, Inc. · 2011
  7. Descendant · cites it directly · 1 of its ownK133207 Staxx (R) SystemSpine Wave, Inc. · 2013
  8. Descendant · 2 generations on · 0 of its ownK142996 StaXx (R) XD SystemSpine Wave, Inc. · 2015
  9. Descendant · cites it directly · 0 of its ownK140563 Lateral VBR SystemNu Vasive, Incorporated · 2014
Show all 10 generations
  1. Root · 10 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 9 generations backK012254 VBROsteotech, Inc. · 2001
  3. 8 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 7 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 6 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 5 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. 4 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. 3 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. 2 generations backK062132 Avs PL Peek Spacer SystemStryker Spine · 2006
  10. 1 generation backK070218 Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated · 2007
  11. This deviceK102315 Staxx XDL SystemSpine Wave, Inc. · 2011

Most influential descendants

Showing 3 of 3 · See all
  • K133207Staxx (R) SystemSpine Wave, Inc. · 2013 · cites it directly1descendant
  • K142996StaXx (R) XD SystemSpine Wave, Inc. · 2015 · 2 generations on0descendants
  • K140563Lateral VBR SystemNu Vasive, Incorporated · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−9K012254VBROsteotech, Inc.2001—
−8K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−7K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−6K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−5K040731Stryker Spine Vertebral SpacerStryker Spine2004—
−4K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
−3K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
−2K062132Avs PL Peek Spacer SystemStryker Spine2006—
−1K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated2007—
0 (this device)K102315Staxx XDL SystemSpine Wave, Inc.2011—
+1K133207Staxx (R) SystemSpine Wave, Inc.2013—
+2K142996StaXx (R) XD SystemSpine Wave, Inc.2015—
+1K140563Lateral VBR SystemNu Vasive, Incorporated2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199810
199910
200010
200160
200250
2003120
2004110
200550
200620
200910
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201510
FIG. 1 — Lineage of K102315, 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
*K052670Staxx XD System
Summary page 1
…ollowing devices: Predicate Device Manufacturer 510(k) No. K052670 StaXx® XO System Spine Wave, Inc. K09031 5…
Spine Wave, Inc.2006—
*K090315Staxx XD System
Summary page 1
…510(k) No. K052670 StaXx® XO System Spine Wave, Inc. K09031 5 K10 1288 Nuvasive CoRoenf ' system NuVasi…
Spine Wave, Inc.2009—
*K101288Staxx XD System
Cleared while this submission was under review
Summary page 1
…K052670 StaXx® XO System Spine Wave, Inc. K09031 5 K10 1288 Nuvasive CoRoenf ' system NuVasive, Inc. K052210 Exactech Octane Device Exactec…
Spine Wave, Inc.20101
*K052210Nuvasive Coroent Extensure System
Summary page 1
…K09031 5 K10 1288 Nuvasive CoRoenf ' system NuVasive, Inc. K052210 Exactech Octane Device Exactech, Inc. K070218 Concorde Bullet Device DePuy S…
Nuvasive, Inc.2005—
*K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)
Summary page 1
…K10 1288 Nuvasive CoRoenf ' system NuVasive, Inc. K052210 Exactech Octane Device Exactech, Inc. K070218 Concorde Bullet Device DePuy Spine, Inc. K052746 5. Device Description The Sta)x® XDL System is…
Vertiflex (Tm), Incorporated2007—
*K052746Concorde VBR Spinal System
Summary page 1
…K052210 Exactech Octane Device Exactech, Inc. K070218 Concorde Bullet Device DePuy Spine, Inc. K052746 5. Device Description The Sta)x® XDL System is composed of wafers that are stacked into an expandable implant to adjust th…
Depuy Spine, Inc.2005—

Also cleared against K052670: 4 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K133207Staxx (R) SystemSpine Wave, Inc.20131
K140563Lateral VBR SystemNu Vasive, Incorporated20140

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 5 companies; a new generation was cleared every 9 months on median.
  • 6 of the 57 ancestors have a recall of any class.
  • Of its descendants, K133207 (Spine Wave, Inc., 2013) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K052670.

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. 2011, this device’s year, is highlighted.

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 StaXx® XDL 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 used with autograft or allograft and supplemental spinal fixation.

Indications for use as stated in the FDA summary.

Also cleared against K052670

4 other devices cite the same predicate.

  • K140563Lateral VBR SystemNu Vasive, Incorporated · 2014
  • K111469Staxxsd SystemSpine Wave, Inc. · 2011
  • K090315Staxx XD SystemSpine Wave, Inc. · 2009
  • K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine · 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/K102315 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102315: Staxx XDL System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102315

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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