510(k) Report

510(k) · Cleared

Cleared

Stryker Spine Avs TL Peek Spacer

K042571510(k) TraditionalCleared Feb 11, 2005143-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

Stryker Spine · MQP Spinal Vertebral Body Replacement Device

Cleared on Feb 11, 2005 as substantially equivalent to K040731 (Stryker Spine, 2004) and 3 other predicates after a 143-day review. Its family tree reaches back 6 generations to 2001. 2 of the 912 devices in its family, counting itself, have a Class I recall. 894 later devices descend from it.

Decided
Feb 11, 2005
Review
143 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K003155 (2001). 17 ancestors in all, the oldest K841189 (1984). 894 later devices descend from it, 5 citing it directly. 2 of the 912 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2001: 4 other ancestors1984: 1 other ancestor2004: 2 other ancestors1999: 1 other ancestor2003: 1 other ancestor2000: 1 other ancestor2002: 1 other ancestor2005: 3 descendants cleared, 1 with a Class I recall12012: 11 descendants cleared2006: 5 descendants cleared2013: 10 descendants cleared2014: 26 descendants cleared2011: 8 descendants cleared2015: 22 descendants cleared2008: 2 descendants cleared2009: 2 descendants cleared2019: 76 descendants cleared2020: 82 descendants cleared2017: 63 descendants cleared2023: 92 descendants cleared2007: 1 descendant cleared2018: 62 descendants cleared2010: 2 descendants cleared2021: 74 descendants cleared, 1 with a Class I recall12016: 34 descendants cleared2022: 80 descendants cleared2025: 77 descendants cleared2024: 92 descendants cleared2026: 70 descendants 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 · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 4 other ancestors4 generations back: 2 other ancestors 1 generation forward: 5 descendants, 1 with a Class I recall12 generations forward: 19 descendants3 generations forward: 59 descendants4 generations forward: 115 descendants5 generations forward: 163 descendants6 generations forward: 191 descendants7 generations forward: 141 descendants8 generations forward: 100 descendants9 generations forward: 58 descendants, 1 with a Class I recall110 generations forward: 31 descendants11 generations forward: 9 descendants12 generations forward: 3 descendants K040731 · 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. · 2001−50+5+10
  1. Root · 6 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 5 generations backK012254 VBROsteotech, Inc. · 2001
  3. 4 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 3 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 2 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 1 generation backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. This deviceK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. Descendant · cites it directly · 892 of its ownK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. Descendant · cites it directly · 829 of its ownK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  10. Descendant · cites it directly · 789 of its ownK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
  11. Descendant · 2 generations on · 788 of its ownK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
  12. Descendant · 2 generations on · 554 of its ownK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009

Showing 5 of 894 descendants. See all descendants

Descendants cleared per year

2005: 32006: 52007: 12008: 22009: 22010: 22011: 82012: 112013: 102014: 262015: 222016: 342017: 632018: 622019: 762020: 822021: 742022: 802023: 922024: 922025: 772026: 70
2005high 92 (2023) · low 1 (2007)2026

Class I recalls in this family

  • K051781 Graftcage TLXcites it directly · 2005
  • K211616 ExcelsiusHub9 generations on · 2021

Most influential descendants

Showing 5 of 894 · See all
  • K050624Stryker Spine Avs PL Peek SpacerStryker Spine · 2005 · cites it directly892descendants
  • K051205Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005 · cites it directly829descendants
  • K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006 · cites it directly789descendants
  • K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc. · 2008 · 2 generations on788descendants
  • K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009 · 2 generations on554descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−5K012254VBROsteotech, Inc.2001—
−4K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−3K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−2K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−1K040731Stryker Spine Vertebral SpacerStryker Spine2004—
0 (this device)K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
+1K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
+1K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005—
+1K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006—
+2K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace…Aesculap Implant Systems, Inc.20081
+2K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199910
200010
200140
200210
200310
200420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200531
200650
200710
200820
200920
201020
201180
2012110
2013100
2014260
2015220
2016340
2017630
2018620
2019760
2020820
2021741
2022800
2023920
2024920
2025770
2026700
FIG. 1 — Lineage of K042571, 2001–2026Source: 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.

2 devices in this family have a Class I recall. 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K040731Stryker Spine Vertebral Spacer
Summary page 1
…ral Body Fixation Orthosis 21 CER 888.3060 Device Panel/ Product Code: MQP: Spinal Vertebral Body Replacement Device Predicate Devices: Stryker Spine Vertebral Spacer [K04073 1] DePuy AcroMed T M , Inc. Surgical Titanium MeshTm System [K003043] Medtronic Sofamor Danek VERTE-STACK TMSpinal System [K03 1780…
Stryker Spine2004—
*K003043Surgical Titanium Mesh System
Summary page 1
…de: MQP: Spinal Vertebral Body Replacement Device Predicate Devices: Stryker Spine Vertebral Spacer [K04073 1] DePuy AcroMed T M , Inc. Surgical Titanium MeshTm System [K003043] Medtronic Sofamor Danek VERTE-STACK TMSpinal System [K03 1780] Rezaian Spinal Fixator [K841 1891 Product Description: The Stryk…
Depuyacromed2001—
*K031780Verte-Stack Spinal System
Summary page 1
…evices: Stryker Spine Vertebral Spacer [K04073 1] DePuy AcroMed T M , Inc. Surgical Titanium MeshTm System [K003043] Medtronic Sofamor Danek VERTE-STACK TMSpinal System [K03 1780] Rezaian Spinal Fixator [K841 1891 Product Description: The Stryker Spine AVSm TL Peek Spacer inserts between vertebral bodies i…
Medtronic Sofamor Danek2003—
*K841189Oec/Rezaian Spinal Fixator
Summary page 1
…acer [K04073 1] DePuy AcroMed T M , Inc. Surgical Titanium MeshTm System [K003043] Medtronic Sofamor Danek VERTE-STACK TMSpinal System [K03 1780] Rezaian Spinal Fixator [K841 1891 Product Description: The Stryker Spine AVSm TL Peek Spacer inserts between vertebral bodies in the anterior thoracic and lumbar…
Orthopedic Equipment Co., Inc.1984—

Also cleared against K040731: 2 other devices →

What descends from it? (894)

See all 894

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

NumberDeviceApplicantDecidedDescendants
K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005892
K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829
K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789
K120345Honour Spacer SystemNexxt Spine, LLC2012212
K051781Graftcage TLX Class IOsteotech, Inc.20050

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K051781Graftcage TLXOsteotech, Inc. · 2005 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 9 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 9 months on median.
  • 1 of the 17 ancestors has a recall of any class.
  • Of its descendants, K050624 (Stryker Spine, 2005) has gone furthest, with 892 descendants of its own.
  • 2 other devices also cite its predicate K040731.

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 Stryker Spine AVS TM TL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material…

Read the full statement (124 words)

The Stryker Spine AVS TM TL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

It is recommended to pack bone graft material inside the implant.

The Stryker Spine AVSTM TL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVSTM TL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

Indications for use as stated in the FDA summary.

Also cleared against K040731

2 other devices cite the same predicate.

  • K051205Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  • K050624Stryker Spine Avs PL Peek SpacerStryker Spine · 2005

More from Stryker Spine

92 FDA decisions under this applicant name. See the company

  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System…Stryker Spine · 2024
  • K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2024
  • K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA®…Stryker Spine · 2023

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/K042571 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042571: Stryker Spine Avs TL Peek Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042571

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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