510(k) · Cleared
ClearedAvs Asl Peek Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · MQP Spinal Vertebral Body Replacement Device
Cleared on Aug 3, 2006 as substantially equivalent to K051205 (Stryker Spine, 2005) after a 35-day review. Its family tree reaches back 9 generations to 2001. 213 later devices descend from it.
- Decided
- Aug 3, 2006
- Review
- 35 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K003155 (2001). 27 ancestors in all, the oldest K841189 (1984). 213 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 5 generations between
- 3 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 2 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 1 generation backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- This deviceK061836 Avs Asl Peek Spacer SystemStryker Spine · 2006
- Descendant · cites it directly · 212 of its ownK120345 Honour Spacer SystemNexxt Spine, LLC · 2012
- Descendant · 2 generations on · 145 of its ownK171140 Matrixx SystemNexxt Spine, LLC · 2017
- Descendant · 2 generations on · 106 of its ownK141376 Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx…Nexxt Spine, LLC · 2014
- Descendant · 3 generations on · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · 4 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations backK012254 VBROsteotech, Inc. · 2001
- 7 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 6 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 5 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 4 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 3 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 2 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 1 generation backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- This deviceK061836 Avs Asl Peek Spacer SystemStryker Spine · 2006
Showing 5 of 213 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 213 · See all- K120345Honour Spacer SystemNexxt Spine, LLC · 2012 · cites it directly212descendants
- K171140Matrixx SystemNexxt Spine, LLC · 2017 · 2 generations on145descendants
- K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC · 2014 · 2 generations on106descendants
- K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018 · 3 generations on100descendants
- K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 4 generations on99descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −8 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −7 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −6 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −5 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −4 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −3 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −2 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −1 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| 0 (this device) | K061836 | Avs Asl Peek Spacer System | Stryker Spine | 2006 | — |
| +1 | K120345 | Honour Spacer System | Nexxt Spine, LLC | 2012 | — |
| +2 | K171140 | Matrixx System | Nexxt Spine, LLC | 2017 | — |
| +2 | K141376 | Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure… | Nexxt Spine, LLC | 2014 | — |
| +3 | K181435 | ATEC Cervical Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +4 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 23 | 0 |
| 2021 | 14 | 0 |
| 2022 | 30 | 0 |
| 2023 | 29 | 0 |
| 2024 | 27 | 0 |
| 2025 | 32 | 0 |
| 2026 | 29 | 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? (1)
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 |
|---|---|---|---|
| * | K051205 | Stryker Spine Avs Asl Peek SpacerSummary page 1…ssion is intended to introduce sixteen new sizes of the AVSTM AS PEEK Spacer to the Stryker Spine AVSTM ASL PEEK Spacer, determined Substantially Equivalent via 5 10(k) #K051205. The new sizes all have the Anterior/Posterior (AP) and Medial/Lateral (ML) footprint of 12mm x 14mm, and range in height from 9m… | 2005 |
What descends from it? (213)
See all 2131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120345 | Honour Spacer System | 2012 | 212 |
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 8 months on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K120345 (Nexxt Spine, LLC, 2012) has gone furthest, with 212 descendants of its own.
- 1 other device also cites its predicate K051205.
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.
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 Stryker Spine AVS ASL 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 (123 words)
The Stryker Spine AVS ASL 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 AVS ASL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS ASL 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.
https://510kreport.com/device/K061836 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061836: Avs Asl Peek Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061836
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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