510(k) · Cleared
ClearedPathway
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 May 1, 2008 as substantially equivalent to K071724 (Spinal Elements, Inc., 2007) and 3 other predicates after an 87-day review. Its family tree reaches back 5 generations to 1984. 188 later devices descend from it.
- Decided
- May 1, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K841189 (1984). 9 ancestors in all. 188 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 4 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 3 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 2 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 1 generation backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- This deviceK080281 PathwayCustom Spine, Inc. · 2008
- Descendant · cites it directly · 169 of its ownK151310 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- Descendant · 2 generations on · 166 of its ownK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- Descendant · 3 generations on · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- Descendant · 4 generations on · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- Descendant · 5 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
Showing 5 of 188 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 188 · See all- K151310Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · cites it directly169descendants
- K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · 2 generations on166descendants
- K171496Tritanium C Anterior Cervical CageStryker Spine · 2017 · 3 generations on129descendants
- K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018 · 4 generations on106descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 5 generations on104descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −4 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −3 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −2 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −1 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| 0 (this device) | K080281 | Pathway | Custom Spine, Inc. | 2008 | — |
| +1 | K151310 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| +2 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| +3 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| +4 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| +5 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 14 | 0 |
| 2020 | 14 | 0 |
| 2021 | 13 | 0 |
| 2022 | 18 | 0 |
| 2023 | 24 | 0 |
| 2024 | 28 | 0 |
| 2025 | 31 | 0 |
| 2026 | 30 | 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? (4)
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 |
|---|---|---|---|
| * | K071724 | LucentSummary page 1…ntervertebral body fusion device ClassificationPanel: Orthopedics Product Code: MAX ProprietaryName: PATHWAY PredicateDevices: Spinal Elements Lucent (K071724), Depuy Acromed ' Stackable Cage" System (K990148, K001340, K030833) Device Description: The PATHWAY Inte… | 2007 |
| * | K990148 | Stackable Cage SystemSummary page 1…uct Code: MAX ProprietaryName: PATHWAY PredicateDevices: Spinal Elements Lucent (K071724), Depuy Acromed ' Stackable Cage" System (K990148, K001340, K030833) Device Description: The PATHWAY Interbody Fusion Device is made from Polyetheretherketon… | 1999 |
| * | K001340 | Stackable Cage SystemSummary page 1…MAX ProprietaryName: PATHWAY PredicateDevices: Spinal Elements Lucent (K071724), Depuy Acromed ' Stackable Cage" System (K990148, K001340, K030833) Device Description: The PATHWAY Interbody Fusion Device is made from Polyetheretherketone (PEEK O… | 2000 |
| * | K030833 | Depuy Acromed VBR SystemSummary page 1…AX ProprietaryName: PATHWAY PredicateDevices: Spinal Elements Lucent (K071724), Depuy Acromed ' Stackable Cage" System (K990148, K001340, K030833) Device Description: The PATHWAY Interbody Fusion Device is made from Polyetheretherketone (PEEK OPTIMA TM)… | 2003 |
What descends from it? (188)
See all 1883 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 24 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K151310 (Amendia, Inc., 2016) has gone furthest, with 169 descendants of its own.
- 38 other devices also cite its predicate K071724.
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 PATHWAY Interbody Fusion Device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S 1) 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 1) 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:
Transforaminal Lumbar Interbody Fusion (TLIF)
Used as a TLIF, a single device is implanted in the appropriate location to provide support for a transforaminal approached surgery
Posterior Lumbar Interbody Fusion (PLIF)
Used as a PLIF, multiple devices are implanted in the appropriate locations to provide support to the spine for a posterior surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080281 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080281: Pathway.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080281
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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