510(k) · Cleared
ClearedPathway Ivb/VBR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Custom Spine, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 22, 2009 as substantially equivalent to K043479 (Ldr Spine USA, 2005) and 2 other predicates after a 92-day review. Its family tree reaches back 7 generations to 1984. 296 later devices descend from it.
- Decided
- Dec 22, 2009
- Review
- 92 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K841189 (1984). 25 ancestors in all. 296 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 5 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 4 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 2 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 1 generation backK043479 MC+ Partial VBRLdr Spine USA · 2005
- This deviceK092904 Pathway Ivb/VBRCustom Spine, Inc. · 2009
- Descendant · cites it directly · 291 of its ownK101812 Construx Mini Peek Spacer SystemOrthofix, Inc. · 2010
- Descendant · 2 generations on · 289 of its ownK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- Descendant · 2 generations on · 281 of its ownK132999 Cervical Stand Alone SystemOrthofix, Inc. · 2014
- Descendant · 2 generations on · 280 of its ownK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- Descendant · 3 generations on · 202 of its ownK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
Showing 5 of 296 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 296 · See all- K101812Construx Mini Peek Spacer SystemOrthofix, Inc. · 2010 · cites it directly291descendants
- K121649Construx Mini Peek TI Spacer SystemOrthofix · 2012 · 2 generations on289descendants
- K132999Cervical Stand Alone SystemOrthofix, Inc. · 2014 · 2 generations on281descendants
- K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc. · 2015 · 2 generations on280descendants
- K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC · 2015 · 3 generations on202descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −6 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −5 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −4 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −2 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −1 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| 0 (this device) | K092904 | Pathway Ivb/VBR | Custom Spine, Inc. | 2009 | — |
| +1 | K101812 | Construx Mini Peek Spacer System | Orthofix, Inc. | 2010 | — |
| +2 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| +2 | K132999 | Cervical Stand Alone System | Orthofix, Inc. | 2014 | — |
| +2 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| +3 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 15 | 0 |
| 2018 | 12 | 0 |
| 2019 | 22 | 0 |
| 2020 | 23 | 0 |
| 2021 | 25 | 0 |
| 2022 | 23 | 0 |
| 2023 | 33 | 0 |
| 2024 | 39 | 0 |
| 2025 | 47 | 0 |
| 2026 | 38 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K043479 | MC+ Partial VBRSummary page 1…Device Product Codes: MQP, 001' Predicate Devices Interbody Fusion Device (P980048), and LDR Spine MC+ (K(043479), Zimmer Spine BAK/C Cervical X-Spine Calix wSpinal Implant (K083637) Device Description… | 2005 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…r: 21 CFR 888.3060, 21 CFR 888.3080 Device Product Codes: MQP, 001' Predicate Devices Interbody Fusion Device (P980048), and LDR Spine MC+ (K(043479), Zimmer Spine BAK/C Cervical X-Spine Calix wSpinal Implant (K083637) Device Description… | 2001 |
| * | K083637 | Calix Spinal Implant SystemSummary page 1…Interbody Fusion Device (P980048), and LDR Spine MC+ (K(043479), Zimmer Spine BAK/C Cervical X-Spine Calix wSpinal Implant (K083637) Device Description made from PEEK OPTIMA LT-1 The PATH WAY ACIF is… | 2009 |
What descends from it? (296)
See all 2963 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 25 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K101812 (Orthofix, Inc., 2010) has gone furthest, with 291 descendants of its own.
- 17 other devices also cite its predicate K043479.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
When used as an intervertebral body fusion device, the Custom Spine PATHWAY ACIF is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should…
Read the full statement (186 words)
When used as an intervertebral body fusion device, the Custom Spine PATHWAY ACIF is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should receive 6 weeks of non-operative treatment prior to treatment with the Custom Spine ACIF.
When used as a vertebral body replacement, the Custom Spine PATHWAY ACIF is intended for use in the thoracic and/or throcolumbar spine (TI-L-5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e. partial or total vertebrectomy procedures) due to tumor or trauma (i.e. fracture). The PATHWAY ACIF, when used as a vertebral body replacement, can be packed with autograft.
For all indications, the device is intended to be used with supptemental fixation systems that have been cleared for use in cervical, thoracic, or lumbar spine (posterior pedicle screw systems, anterior plate systems, and anterior screw and rod systems).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092904 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092904: Pathway Ivb/VBR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092904
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