510(k) · Cleared
ClearedAvs PL Peek Spacers, Models 48351 and 48353
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 Mar 27, 2008 as substantially equivalent to K073470 (Stryker Spine, 2008) and 1 other predicate after a 9-day review. Its family tree reaches back 4 generations to 2001. 1 of the 1,100 devices in its family, counting itself, has a Class I recall. 1,091 later devices descend from it.
- Decided
- Mar 27, 2008
- Review
- 9 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K010530 (2001). 8 ancestors in all, the oldest P950002 (1996). 1,091 later devices descend from it, 6 citing it directly. 1 of the 1,100 devices in this family, counting this one, has a Class I recall.
- 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 deviceK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- Descendant · cites it directly · 854 of its ownK081395 Solitaire Peek-Optima Anterior Spinal SystemBiomet Spine · 2008
- Descendant · cites it directly · 837 of its ownK082014 Stryker Spine Avs PL Peek SpacersStryker Corp. · 2008
- Descendant · 2 generations on · 834 of its ownK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- Descendant · cites it directly · 756 of its ownK090816 Stryker Spine Avs PL Peek SpacersStryker Corp. · 2009
- Descendant · 3 generations on · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
Showing 5 of 1,091 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 1,091 · See all- K081395Solitaire Peek-Optima Anterior Spinal SystemBiomet Spine · 2008 · cites it directly854descendants
- K082014Stryker Spine Avs PL Peek SpacersStryker Corp. · 2008 · cites it directly837descendants
- K083475Lucent MagnumSpinal Elements, Inc. · 2009 · 2 generations on834descendants
- K090816Stryker Spine Avs PL Peek SpacersStryker Corp. · 2009 · cites it directly756descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 3 generations on744descendants
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) | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| +1 | K081395 | Solitaire Peek-Optima Anterior Spinal System | Biomet Spine | 2008 | — |
| +1 | K082014 | Stryker Spine Avs PL Peek Spacers | Stryker Corp. | 2008 | — |
| +2 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| +1 | K090816 | Stryker Spine Avs PL Peek Spacers | Stryker Corp. | 2009 | — |
| +3 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
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 |
|---|---|---|
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 10 | 0 |
| 2011 | 14 | 0 |
| 2012 | 19 | 0 |
| 2013 | 17 | 0 |
| 2014 | 34 | 0 |
| 2015 | 37 | 0 |
| 2016 | 67 | 0 |
| 2017 | 88 | 0 |
| 2018 | 89 | 0 |
| 2019 | 89 | 0 |
| 2020 | 96 | 0 |
| 2021 | 84 | 1 |
| 2022 | 81 | 0 |
| 2023 | 100 | 0 |
| 2024 | 101 | 0 |
| 2025 | 81 | 0 |
| 2026 | 74 | 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? (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 |
|---|---|---|---|
| * | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXXSummary page 1…l: Vikki.O'Connorn Stryker.com Date Summary Prepared: March 13, 2008 Predicate Device AVS PL PEEK Spacer, K073470 DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine… | 2008 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…K Spacer, K073470 DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine System: P960025 (i.e., Brantigan Cage) Predicate Device Information The subject AVS PL PEEK Spacers and the predicates AVS PL… | 1999 |
What descends from it? (1,091)
See all 1,0916 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081395 | Solitaire Peek-Optima Anterior Spinal System | 2008 | 854 |
| K082014 | Stryker Spine Avs PL Peek Spacers | 2008 | 837 |
| K090816 | Stryker Spine Avs PL Peek Spacers | 2009 | 756 |
| K100865 | Ava Navigator Peek Spacers, Model 48392XXX, 48393XXX | 2010 | 637 |
| K081636 | Peek-Optima Alif Spacer | 2008 | 542 |
| K081196 | Spinal Usa VBR System | 2008 | 13 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 6 months on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K081395 (Biomet Spine, 2008) has gone furthest, with 854 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. 2008, 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/K080758 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080758: Avs PL Peek Spacers, Models 48351 and 48353.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080758
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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