510(k) · Cleared
ClearedAvs PL Peek Spacers, Models 48351XXX and 48353XXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 6, 2008 as substantially equivalent to P950019 (Stryker Spine, 1996) and 2 other predicates after an 87-day review. Its family tree reaches back 3 generations to 2001. 1 of the 1,110 devices in its family, counting itself, has a Class I recall. 1,102 later devices descend from it.
- Decided
- Mar 6, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K010530 (2001). 7 ancestors in all, the oldest P950002 (1996). 1,102 later devices descend from it, 18 citing it directly. 1 of the 1,110 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 2 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 1 generation backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- This deviceK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- Descendant · cites it directly · 1,091 of its ownK080758 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 · 757 of its ownK083661 Avs TL Peek SpacersStryker Corp. · 2009
Showing 5 of 1,102 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 1,102 · See all- K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008 · cites it directly1,091descendants
- 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
- K083661Avs TL Peek SpacersStryker Corp. · 2009 · cites it directly757descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −2 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −1 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| 0 (this device) | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| +1 | 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 | K083661 | Avs TL Peek Spacers | Stryker Corp. | 2009 | — |
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 | 5 | 0 |
| 2009 | 9 | 0 |
| 2010 | 12 | 0 |
| 2011 | 14 | 0 |
| 2012 | 21 | 0 |
| 2013 | 18 | 0 |
| 2014 | 34 | 0 |
| 2015 | 38 | 0 |
| 2016 | 67 | 0 |
| 2017 | 88 | 0 |
| 2018 | 89 | 0 |
| 2019 | 89 | 0 |
| 2020 | 96 | 0 |
| 2021 | 84 | 1 |
| 2022 | 82 | 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? (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 |
|---|---|---|---|
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 1…888.3080 and Number Product Code MAX Predicate Devices Stryker Spine Ray Threaded Fusicit-C-age (TFC-)TMwith instrumentation: P950019; DePuy AcroMed, Inc. Lumbar 1/1F C-age®0 with VSP Spine Systemn: P960025.… | 1996 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…with instrumentation: P950019; DePuy AcroMed, Inc. Lumbar 1/1F C-age®0 with VSP Spine Systemn: P960025. Synthes Spine SynFix'T m - LR: K072253. Device Description The AVS PL Peek Spacers are intcrvcrte… | 1999 |
| * | K072253 | Synfix-LR SpacerSummary page 1…DePuy AcroMed, Inc. Lumbar 1/1F C-age®0 with VSP Spine Systemn: P960025. Synthes Spine SynFix'T m - LR: K072253. Device Description The AVS PL Peek Spacers are intcrvcrtebral body fusion devices intended for us… | 2007 |
What descends from it? (1,102)
See all 1,10218 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | 2008 | 1,091 |
| K081395 | Solitaire Peek-Optima Anterior Spinal System | 2008 | 854 |
| K082014 | Stryker Spine Avs PL Peek Spacers | 2008 | 837 |
| K083661 | Avs TL Peek Spacers | 2009 | 757 |
| K090816 | Stryker Spine Avs PL Peek Spacers | 2009 | 756 |
| K090166 | Avs Anterior Large Peek Spacers | 2009 | 683 |
| K120869 | Anchor-L Lumbar Cage | 2012 | 638 |
| K100865 | Ava Navigator Peek Spacers, Model 48392XXX, 48393XXX | 2010 | 637 |
| K081636 | Peek-Optima Alif Spacer | 2008 | 542 |
| K111792 | Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and Mini | 2012 | 470 |
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 3 companies; a new generation was cleared every 6 months on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K080758 (Stryker Corp., 2008) has gone furthest, with 1,091 descendants of its own.
- 37 other devices also cite its predicate P950019.
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 ] 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 ] 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/K073470 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073470
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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