510(k) · Cleared
ClearedPathway Avid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Custom Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Feb 6, 2012 as substantially equivalent to K090566 (Custom Spine, Inc., 2009) after a 231-day review. Its family tree reaches back 6 generations to 1984. 95 later devices descend from it.
- Decided
- Feb 6, 2012
- Review
- 231 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K841189 (1984). 16 ancestors in all. 95 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 4 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 3 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 2 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 1 generation backK090566 Pathway AvidCustom Spine, Inc. · 2009
- This deviceK111726 Pathway AvidCustom Spine, Inc. · 2012
- Descendant · cites it directly · 88 of its ownK123913 Latis SpacerGlobus Medical, Inc. · 2013
- Descendant · 2 generations on · 55 of its ownK171848 FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy…Globus Medical, Inc. · 2017
- Descendant · 2 generations on · 41 of its ownK160646 XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc. · 2016
- Descendant · 3 generations on · 39 of its ownK202587 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2020
- Descendant · 4 generations on · 38 of its ownK211805 IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody…Alphatec Spine, Inc. · 2021
Showing 5 of 95 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 95 · See all- K123913Latis SpacerGlobus Medical, Inc. · 2013 · cites it directly88descendants
- K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc. · 2017 · 2 generations on55descendants
- K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc. · 2016 · 2 generations on41descendants
- K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2020 · 3 generations on39descendants
- K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc. · 2021 · 4 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −5 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −4 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −3 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −2 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −1 | K090566 | Pathway Avid | Custom Spine, Inc. | 2009 | — |
| 0 (this device) | K111726 | Pathway Avid | Custom Spine, Inc. | 2012 | — |
| +1 | K123913 | Latis Spacer | Globus Medical, Inc. | 2013 | — |
| +2 | K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers… | Globus Medical, Inc. | 2017 | — |
| +2 | K160646 | XYcor® Expandable Spinal Spacer System | Alphatec Spine, Inc. | 2016 | — |
| +3 | K202587 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2020 | — |
| +4 | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi… | Alphatec Spine, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 13 | 0 |
| 2024 | 18 | 0 |
| 2025 | 19 | 0 |
| 2026 | 16 | 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? (1)
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 |
|---|---|---|---|
| * | K090566 | Pathway AvidSummary page 1…mmon Name: Intervertebral Body Fusion Device Device Classification: Class 11 Regulation Number: 21 CFR 888.3080 Device Product Codes: MAX Predicate Devices PATHWAY AVID K090566 Description of Modified Device The proposed modification subject device is to be provided to the users in one of two configurat… | 2009 |
What descends from it? (95)
See all 952 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 28 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K123913 (Globus Medical, Inc., 2013) has gone furthest, with 88 descendants of its own.
- 6 other devices also cite its predicate K090566.
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. 2012, 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 PATHWAY AVID Intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a…
Read the full statement (161 words)
The PATHWAY AVID Intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved level(s).
The device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rods systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device. The PATHWAY AVID Intervertebral body fusion device must be inserted using a transforaminal approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111726 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111726: Pathway Avid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111726
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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