510(k) · Cleared
ClearedAvs Anterior Large Peek Spacers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 22, 2009 as substantially equivalent to K073470 (Stryker Spine, 2008) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 2001. 683 later devices descend from it.
- Decided
- Apr 22, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K010530 (2001). 11 ancestors in all, the oldest P950002 (1996). 683 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 3 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 2 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 1 generation backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- This deviceK090166 Avs Anterior Large Peek SpacersStryker Corp. · 2009
- Descendant · cites it directly · 637 of its ownK093864 Avs Align Peek Spacers Model 48328XXX, 48326XXXStryker Corp. · 2010
- Descendant · 2 generations on · 636 of its ownK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- Descendant · cites it directly · 470 of its ownK111792 Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model…Signus Medizintechnik GmbH · 2012
- Descendant · 3 generations on · 469 of its ownK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- Descendant · 2 generations on · 462 of its ownK131372 Mobis IISignus Medizintechnik GmbH · 2013
Showing 5 of 683 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 683 · See all- K093864Avs Align Peek Spacers Model 48328XXX, 48326XXXStryker Corp. · 2010 · cites it directly637descendants
- K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation · 2015 · 2 generations on636descendants
- K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH · 2012 · cites it directly470descendants
- K143616AccuLIF TL and PL CageStryker Corporation · 2015 · 3 generations on469descendants
- K131372Mobis IISignus Medizintechnik GmbH · 2013 · 2 generations on462descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −3 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −2 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −1 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| 0 (this device) | K090166 | Avs Anterior Large Peek Spacers | Stryker Corp. | 2009 | — |
| +1 | K093864 | Avs Align Peek Spacers Model 48328XXX, 48326XXX | Stryker Corp. | 2010 | — |
| +2 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| +1 | K111792 | Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and… | Signus Medizintechnik GmbH | 2012 | — |
| +3 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| +2 | K131372 | Mobis II | Signus Medizintechnik GmbH | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 21 | 0 |
| 2017 | 44 | 0 |
| 2018 | 51 | 0 |
| 2019 | 57 | 0 |
| 2020 | 70 | 0 |
| 2021 | 59 | 0 |
| 2022 | 69 | 0 |
| 2023 | 84 | 0 |
| 2024 | 88 | 0 |
| 2025 | 68 | 0 |
| 2026 | 57 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXXSummary page 1…on Name Intervertebral body fusion device, 21 CFR 888.3080 and Number Product Code MAX Predicate Devices Stryker Spine AVS ® PL PEEK Spacers: K073470 Pillar XL Peek Spacers: K082235 DePuy AcroMed, Inc. Lumbar I/F Cage® (i.e., B… | 2008 |
| * | K082235 | Blackstone Pillar XL Peek SpacersSummary page 1…8.3080 and Number Product Code MAX Predicate Devices Stryker Spine AVS ® PL PEEK Spacers: K073470 Pillar XL Peek Spacers: K082235 DePuy AcroMed, Inc. Lumbar I/F Cage® (i.e., Brantigan Cage) with VSP Spine S… | 2008 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…Pillar XL Peek Spacers: K082235 DePuy AcroMed, Inc. Lumbar I/F Cage® (i.e., Brantigan Cage) with VSP Spine System: P960025. Device Description The AVS ® AL Peek Spacers are intervertebral body fusion devices intended… | 1999 |
What descends from it? (683)
See all 6833 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K093864 (Stryker Corp., 2010) has gone furthest, with 637 descendants of its own.
- 17 other devices also cite its predicate K073470.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The Stryker Spine AVS® AL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients…
Read the full statement (132 words)
The Stryker Spine AVS® AL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The AVS ® AL Peek Spacers are to be implanted via an anterior or anterolateral approach.
The AVS® AL PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090166 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090166: Avs Anterior Large Peek Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090166
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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