510(k) · Cleared
ClearedAvs 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 Dec 23, 2009 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) after a 22-day review. Its family tree reaches back 1 generation to 1999. 713 later devices descend from it.
- Decided
- Dec 23, 2009
- Review
- 22 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P960025 (1999). 713 later devices descend from it, 13 citing it directly.
- Root · 1 generation backP960025 Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle…Depuy Spine, Inc. · 1999
- This deviceK093704 Avs PL Peek SpacersStryker Corp. · 2009
- Descendant · cites it directly · 637 of its ownK100865 Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine · 2010
- Descendant · cites it directly · 636 of its ownK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- Descendant · 2 generations on · 469 of its ownK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- Descendant · 2 generations on · 448 of its ownK152304 Tritanium PL CageStryker · 2015 · Recalled
- Descendant · 2 generations on · 390 of its ownK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
Showing 5 of 713 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 713 · 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 · cites it directly636descendants
- K143616AccuLIF TL and PL CageStryker Corporation · 2015 · 2 generations on469descendants
- K152304Tritanium PL CageStryker · 2015 · 2 generations on448descendants
- K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · 2 generations on390descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws | Depuy Spine, Inc. | 1999 | — |
| 0 (this device) | K093704 | Avs PL Peek Spacers | Stryker Corp. | 2009 | — |
| +1 | K100865 | Ava Navigator Peek Spacers, Model 48392XXX, 48393XXX | Stryker Spine | 2010 | — |
| +1 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| +2 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| +2 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| +2 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 10 | 0 |
| 2015 | 7 | 0 |
| 2016 | 21 | 0 |
| 2017 | 49 | 0 |
| 2018 | 46 | 0 |
| 2019 | 58 | 0 |
| 2020 | 70 | 0 |
| 2021 | 62 | 0 |
| 2022 | 76 | 0 |
| 2023 | 87 | 0 |
| 2024 | 84 | 0 |
| 2025 | 70 | 0 |
| 2026 | 60 | 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? (2)
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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…9 Predicate Device AVS8 PL PEEK Spacers and DePuy AcroMed, Inc. Lumbar 1/F7 Cageo with VSP Spine System:-P960025 (i~e., Brantigan Cage) Predicate Device Information The subject AVS PL PEEK Spacers and the predicates AVS PL… | 1999 |
| * | — | AVS® PL PEEK Spacers Named without a submission number |
What descends from it? (713)
See all 71313 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 |
| K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer… | 2015 | 636 |
| K120345 | Honour Spacer System | 2012 | 212 |
| K121254 | Camber Spine Technologies TLS 5.0 Inerbody Cage | 2013 | 40 |
| 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 |
| K111820 | Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage | 2012 | 20 |
| K121567 | Oracle Lumbar Intervertebral Body Fusion Cage System | 2012 | 5 |
| K140564 | BN Lumbar Cage System | 2014 | 3 |
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?
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 SI. 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 SI.
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/K093704 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093704: Avs PL 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/K093704
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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