510(k) · Cleared
ClearedStryker Spine Avs PL 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 24, 2009 as substantially equivalent to K073470 (Stryker Spine, 2008) and 3 other predicates after a 30-day review. Its family tree reaches back 6 generations to 2001. 1 of the 767 devices in its family, counting itself, has a Class I recall. 756 later devices descend from it.
- Decided
- Apr 24, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K010530 (2001). 10 ancestors in all, the oldest P950002 (1996). 756 later devices descend from it, 10 citing it directly. 1 of the 767 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 5 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 4 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 3 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 2 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 1 generation backK082014 Stryker Spine Avs PL Peek SpacersStryker Corp. · 2008
- This deviceK090816 Stryker Spine Avs PL Peek SpacersStryker Corp. · 2009
- Descendant · cites it directly · 637 of its ownK100865 Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine · 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 · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 2 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 3 generations on · 469 of its ownK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
Showing 5 of 756 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 756 · See all- K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine · 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
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · cites it directly588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 2 generations on479descendants
- K143616AccuLIF TL and PL CageStryker Corporation · 2015 · 3 generations on469descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −5 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −4 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −3 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −2 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −1 | K082014 | Stryker Spine Avs PL Peek Spacers | Stryker Corp. | 2008 | — |
| 0 (this device) | K090816 | Stryker Spine Avs PL Peek Spacers | Stryker Corp. | 2009 | — |
| +1 | K100865 | Ava Navigator Peek Spacers, Model 48392XXX, 48393XXX | Stryker Spine | 2010 | — |
| +2 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| +1 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +2 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +3 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 13 | 0 |
| 2016 | 29 | 0 |
| 2017 | 48 | 0 |
| 2018 | 56 | 0 |
| 2019 | 63 | 0 |
| 2020 | 80 | 0 |
| 2021 | 64 | 1 |
| 2022 | 73 | 0 |
| 2023 | 88 | 0 |
| 2024 | 91 | 0 |
| 2025 | 77 | 0 |
| 2026 | 64 | 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.
1 device in this family has 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXXSummary page 1…mail: Vikki.O'ConnorG)Strvker.com Date Summary Prepared: March 18, 2009 Predicate Device AVSTM PL PEEK Spacers (K073470, K080758 and K082014) DePuy AcroMed, Inc. Lumbar INF Cage® with VSP Spine… | 2008 |
| * | K080758 | Avs PL Peek Spacers, Models 48351 and 48353Summary page 1…ki.O'ConnorG)Strvker.com Date Summary Prepared: March 18, 2009 Predicate Device AVSTM PL PEEK Spacers (K073470, K080758 and K082014) DePuy AcroMed, Inc. Lumbar INF Cage® with VSP Spine… | 2008 |
| * | K082014 | Stryker Spine Avs PL Peek SpacersSummary page 1…)Strvker.com Date Summary Prepared: March 18, 2009 Predicate Device AVSTM PL PEEK Spacers (K073470, K080758 and K082014) DePuy AcroMed, Inc. Lumbar INF Cage® with VSP Spine… | 2008 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…58 and K082014) DePuy AcroMed, Inc. Lumbar INF Cage® with VSP Spine System: P960025 (i.e., Brantigan Cage) Predicate Device Information The subject AVSTM PL PEEK Spacers and the predicates… | 1999 |
What descends from it? (756)
See all 75610 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100865 | Ava Navigator Peek Spacers, Model 48392XXX, 48393XXX | 2010 | 637 |
| K141665 | NuVasive CoRoent System | 2015 | 588 |
| K133557 | Juliet LL Lateral Lumbar Cage | 2014 | 147 |
| K140474 | Juliet OL | 2014 | 120 |
| K110783 | Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage | 2011 | 38 |
| K120063 | Venus Lumbar Intervertebral Body Fusion Cage System | 2012 | 37 |
| K121096 | Venus Lumbar Intervertebral Body Fusion Cage System | 2012 | 36 |
| K113540 | Reliance Lumbar Ibf System | 2012 | 12 |
| K121567 | Oracle Lumbar Intervertebral Body Fusion Cage System | 2012 | 5 |
| K181030 | Rubicon Lumbar Interbody Fusion System | 2018 | 0 |
Has anything in its family been recalled? (1 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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 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 6 months on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K100865 (Stryker Spine, 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 PL 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 (129 words)
The Stryker Spine AVS PL 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 PL PEEK Spacers are to be implanted via posterior approach.
The AVS PL PEEK Spacers are intended to be used with supplemental spinal 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/K090816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090816: Stryker Spine Avs PL Peek Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090816
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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