510(k) · Cleared
ClearedAva Navigator Peek Spacers, Model 48392XXX, 48393XXX
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 Aug 11, 2010 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 7 other predicates after a 135-day review. Its family tree reaches back 7 generations to 2001. 637 later devices descend from it.
- Decided
- Aug 11, 2010
- Review
- 135 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 7 generations to K010530 (2001). 14 ancestors in all, the oldest P950002 (1996). 637 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 6 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 5 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 4 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 3 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 2 generations backK082014 Stryker Spine Avs PL Peek SpacersStryker Corp. · 2008
- 1 generation backK090816 Stryker Spine Avs PL Peek SpacersStryker Corp. · 2009
- This deviceK100865 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
- Descendant · 3 generations on · 381 of its ownK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
Showing 5 of 637 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 637 · See all- 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
- K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · 3 generations on381descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −6 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −5 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −4 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −3 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −2 | K082014 | Stryker Spine Avs PL Peek Spacers | Stryker Corp. | 2008 | — |
| −1 | K090816 | Stryker Spine Avs PL Peek Spacers | Stryker Corp. | 2009 | — |
| 0 (this device) | 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 | — |
| +3 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 6 | 0 |
| 2016 | 17 | 0 |
| 2017 | 37 | 0 |
| 2018 | 40 | 0 |
| 2019 | 53 | 0 |
| 2020 | 68 | 0 |
| 2021 | 56 | 0 |
| 2022 | 69 | 0 |
| 2023 | 83 | 0 |
| 2024 | 83 | 0 |
| 2025 | 68 | 0 |
| 2026 | 57 | 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? (8)
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…y equivalent to the devices listed below: * DePuy AcroMed, Inc. Lumbar I/F Cage q with VSP®9 Spine System, PMA# P960025, * Stryker Spine AVSO TL PEEK Spacers, 5 10(k) It K083661, * Stryker Spin… | 1999 |
| * | K083661 | Avs TL Peek SpacersSummary page 1…Inc. Lumbar I/F Cage q with VSP®9 Spine System, PMA# P960025, * Stryker Spine AVSO TL PEEK Spacers, 5 10(k) It K083661, * Stryker Spine AVS®D PL PEEK Spacers, 5 10(k) #s K093704, * K0908 16, K… | 2009 |
| * | K093704 | Avs PL Peek SpacersSummary page 1…0025, * Stryker Spine AVSO TL PEEK Spacers, 5 10(k) It K083661, * Stryker Spine AVS®D PL PEEK Spacers, 5 10(k) #s K093704, * K0908 16, K082014, K080758 and K073470, * LifeSpine Plateau Spacer, 51… | 2009 |
| * | K090816 | Stryker Spine Avs PL Peek SpacersSummary page 1…yker Spine AVSO TL PEEK Spacers, 5 10(k) It K083661, * Stryker Spine AVS®D PL PEEK Spacers, 5 10(k) #s K093704, * K0908 16, K082014, K080758 and K073470, * LifeSpine Plateau Spacer, 510(k) #K08041 11. Device Description… | 2009 |
| * | K082014 | Stryker Spine Avs PL Peek SpacersSummary page 1…AVSO TL PEEK Spacers, 5 10(k) It K083661, * Stryker Spine AVS®D PL PEEK Spacers, 5 10(k) #s K093704, * K0908 16, K082014, K080758 and K073470, * LifeSpine Plateau Spacer, 510(k) #K08041 11. Device Description -Th-e A… | 2008 |
| * | K080758 | Avs PL Peek Spacers, Models 48351 and 48353Summary page 1…PEEK Spacers, 5 10(k) It K083661, * Stryker Spine AVS®D PL PEEK Spacers, 5 10(k) #s K093704, * K0908 16, K082014, K080758 and K073470, * LifeSpine Plateau Spacer, 510(k) #K08041 11. Device Description -Th-e AV-SONavig… | 2008 |
| * | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXXSummary page 1…, 5 10(k) It K083661, * Stryker Spine AVS®D PL PEEK Spacers, 5 10(k) #s K093704, * K0908 16, K082014, K080758 and K073470, * LifeSpine Plateau Spacer, 510(k) #K08041 11. Device Description -Th-e AV-SONavigator PEEK Sp… | 2008 |
| * | K080411 | Plateau Spacer SystemSummary page 1…L PEEK Spacers, 5 10(k) #s K093704, * K0908 16, K082014, K080758 and K073470, * LifeSpine Plateau Spacer, 510(k) #K08041 11. Device Description -Th-e AV-SONavigator PEEK Spacer is intended for use as an interbody fusion… | 2008 |
What descends from it? (637)
See all 6372 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 4 companies; a new generation was cleared every 6 months on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K143163 (Stryker Corporation, 2015) has gone furthest, with 636 descendants of its own.
- 98 other devices also cite its predicate P960025.
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. 2010, 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® Navigator PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative ditc disease (DOD) at one level or two contiguous levels from L2 to Si. ODDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DODD patients may also have up to Grade I spondylolisthesis at the involved level(s). These…
Read the full statement (124 words)
The Stryker Spine AVS® Navigator PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative ditc disease (DOD) at one level or two contiguous levels from L2 to Si.
ODDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DODD 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® Navigator PEEK Spacers are to be implanted via a posterior or posterolateral approach.
The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100865: Ava Navigator Peek Spacers, Model 48392XXX, 48393XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100865
Report an extraction error
Are you the manufacturer?
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