510(k) · Cleared
ClearedAvs TL 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 Feb 27, 2009 as substantially equivalent to K073470 (Stryker Spine, 2008) and 1 other predicate after a 79-day review. Its family tree reaches back 4 generations to 2001. 757 later devices descend from it.
- Decided
- Feb 27, 2009
- Review
- 79 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). 757 later devices descend from it, 15 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 deviceK083661 Avs TL Peek SpacersStryker Corp. · 2009
- Descendant · cites it directly · 641 of its ownK101051 Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine · 2010
- 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 · cites it directly · 470 of its ownK111792 Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model…Signus Medizintechnik GmbH · 2012
- Descendant · 2 generations on · 469 of its ownK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
Showing 5 of 757 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 757 · See all- K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine · 2010 · cites it directly641descendants
- 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
- 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 · 2 generations on469descendants
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) | K083661 | Avs TL Peek Spacers | Stryker Corp. | 2009 | — |
| +1 | K101051 | Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXX | Stryker Spine | 2010 | — |
| +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 | — |
| +1 | K111792 | Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and… | Signus Medizintechnik GmbH | 2012 | — |
| +2 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 9 | 0 |
| 2013 | 6 | 0 |
| 2014 | 11 | 0 |
| 2015 | 9 | 0 |
| 2016 | 24 | 0 |
| 2017 | 55 | 0 |
| 2018 | 57 | 0 |
| 2019 | 61 | 0 |
| 2020 | 72 | 0 |
| 2021 | 64 | 0 |
| 2022 | 76 | 0 |
| 2023 | 88 | 0 |
| 2024 | 89 | 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 |
|---|---|---|---|
| * | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXXSummary page 1…cation Name Intervertebral body fusion device, 21 CFR 888.3080 and Number Product Code MAX Predicate Devices Stryker Spine AVS ® PL PEEK Spacers: K073470 DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine System: P960025. Device Des… | 2008 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…Devices Stryker Spine AVS ® PL PEEK Spacers: K073470 DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine System: P960025. Device Description The AVS® TL Peek Spacers are intervertebral body fusion devices intended for u… | 1999 |
What descends from it? (757)
See all 75715 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101051 | Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXX | 2010 | 641 |
| 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 |
| K111792 | Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and Mini | 2012 | 470 |
| K120345 | Honour Spacer System | 2012 | 212 |
| 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 |
| K092017 | Pivotec Lumbar Interbody Fusion Device (Lifd) | 2009 | 24 |
| K111820 | Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage | 2012 | 20 |
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 12 months on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K101051 (Stryker Spine, 2010) has gone furthest, with 641 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® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft bone 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 (128 words)
The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft bone 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® TL Spacers are to be implanted via posterior approach.
The AVS® TL 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/K083661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083661: Avs TL 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/K083661
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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