510(k) · Cleared
ClearedPathway Model 07XXXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Custom Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 20, 2011 as substantially equivalent to K080281 (Custom Spine, Inc., 2008) after a 27-day review. Its family tree reaches back 6 generations to 1984. 15 later devices descend from it.
- Decided
- Jul 20, 2011
- Review
- 27 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K841189 (1984). 10 ancestors in all. 15 later devices descend from it, 1 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 backK080281 PathwayCustom Spine, Inc. · 2008
- This deviceK111774 Pathway Model 07XXXXCustom Spine · 2011
- Descendant · cites it directly · 14 of its ownK143143 Pathway ElifCustom Spine, Inc. · 2015
- Descendant · 2 generations on · 12 of its ownK153123 Genesys Spine Apache Interbody Fusion SystemGenesys Spine · 2016
- Descendant · 3 generations on · 11 of its ownK161438 Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine · 2016
- Descendant · 3 generations on · 9 of its ownK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
- Descendant · 4 generations on · 7 of its ownK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K143143Pathway ElifCustom Spine, Inc. · 2015 · cites it directly14descendants
- K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine · 2016 · 2 generations on12descendants
- K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine · 2016 · 3 generations on11descendants
- K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019 · 3 generations on9descendants
- K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020 · 4 generations on7descendants
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 | K080281 | Pathway | Custom Spine, Inc. | 2008 | — |
| 0 (this device) | K111774 | Pathway Model 07XXXX | Custom Spine | 2011 | — |
| +1 | K143143 | Pathway Elif | Custom Spine, Inc. | 2015 | — |
| +2 | K153123 | Genesys Spine Apache Interbody Fusion System | Genesys Spine | 2016 | — |
| +3 | K161438 | Genesys Spine Apache® Anterior Lumbar Interbody Fusion System | Genesys Spine | 2016 | — |
| +3 | K182987 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | 2019 | — |
| +4 | K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K080281 | PathwaySummary page 1…vertebral Interbody Fusion Devices Device Classification: Class 11 Regulation Number: 21 CER 888.3080 Device Product Codes: MAX Predicate Devices Custom Spine PATHWAY (K080281) Indications for Use The PATH4WAY Interbody Fusion Device(s) is intended for spinal fusion procedure at one or two contiguous l… | 2008 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143143 | Pathway Elif | 2015 | 14 |
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 27 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K143143 (Custom Spine, Inc., 2015) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K080281.
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. 2011, 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 Interbody Fusion Device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S I) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion…
Read the full statement (214 words)
The PATHWAY Interbody Fusion Device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S I) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The PATHWAY Interbody Fusion device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, anterior plate systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft.
Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY Device.
The PATHWAY device can be used in one of two methods:
TransforaminalLumbar Interbody Fusion (TLIP)
Used as a TLIF, a single device is implanted in the appropriate location (L2-SI1) to provide support for a transforaminal approached surgery.
PosteriorLumbar Interbody Fusion (FLI)
Used as a PLIF, two devices are implanted in the appropriate locations (L2-S 1) to provide support to the spine for a posterior surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111774: Pathway Model 07XXXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111774
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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