510(k) · Cleared
ClearedTi-Diagon Oblique TLIF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camber Spine Technologies · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 15, 2017 as substantially equivalent to K121254 (Camber Spine Technologies, 2013) and 2 other predicates after a 70-day review. Its family tree reaches back 13 generations to 2001. 27 later devices descend from it.
- Decided
- Sep 15, 2017
- Review
- 70 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K003155 (2001). 91 ancestors in all, the oldest K841189 (1984). 27 later devices descend from it, 5 citing it directly.
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations between
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK130573 Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC · 2013
- 1 generation backK133967 Interbody Cage SystemAurora Spine · 2014
- This deviceK172064 Ti-Diagon Oblique TLIFCamber Spine Technologies · 2017
- Descendant · cites it directly · 15 of its ownK212904 SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2021
- Descendant · cites it directly · 11 of its ownK213420 WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation · 2022
- Descendant · 2 generations on · 9 of its ownK222732 WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022
- Descendant · 3 generations on · 8 of its ownK233694 Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024
- Descendant · 2 generations on · 8 of its ownK233414 Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation · 2023
Show all 13 generations
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations backK012254 VBROsteotech, Inc. · 2001
- 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 8 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 7 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 6 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 5 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 4 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK130573 Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC · 2013
- 1 generation backK133967 Interbody Cage SystemAurora Spine · 2014
- This deviceK172064 Ti-Diagon Oblique TLIFCamber Spine Technologies · 2017
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2021 · cites it directly15descendants
- K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation · 2022 · cites it directly11descendants
- K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022 · 2 generations on9descendants
- K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024 · 3 generations on8descendants
- K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation · 2023 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −12 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −11 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −8 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −7 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −3 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −2 | K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif | Tyber Medical, LLC | 2013 | — |
| −1 | K133967 | Interbody Cage System | Aurora Spine | 2014 | — |
| 0 (this device) | K172064 | Ti-Diagon Oblique TLIF | Camber Spine Technologies | 2017 | — |
| +1 | K212904 | SeaSpine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | 2021 | — |
| +1 | K213420 | WaveForm L System, WaveForm TO System, WaveForm TA System | SeaSpine Orthopedics Corporation | 2022 | — |
| +2 | K222732 | WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2022 | — |
| +3 | K233694 | Meridian Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2024 | — |
| +2 | K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | SeaSpine Orthopedics Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 10 | 0 |
| 2004 | 14 | 0 |
| 2005 | 9 | 0 |
| 2007 | 7 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 8 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K121254 | Camber Spine Technologies TLS 5.0 Inerbody CageSummary page 4…II Product Codes: MAX Primary Predicate: Camber Spine Technologies TLS 5.0 Interbody Cage (K121254) Additional Predicate(s): Camber Spine Technologies Diagon Oblique Cage (K134038), and… | 2013 |
| * | K134038 | Camber Spine Diagon Oblique CageSummary page 4…ies TLS 5.0 Interbody Cage (K121254) Additional Predicate(s): Camber Spine Technologies Diagon Oblique Cage (K134038), and Aurora Spine Interbody Fusion System (K133967) Reference Device: Rhausler Plage™… | 2014 |
| * | K133967 | Interbody Cage SystemSummary page 4…dicate(s): Camber Spine Technologies Diagon Oblique Cage (K134038), and Aurora Spine Interbody Fusion System (K133967) Reference Device: Rhausler Plage™ Anterior Cervical Fusion System (K111272) Indications For Use: The Camber Spine… | 2014 |
| † | K111272 | Rhausler Plage Anterior Cervical Fusion System | 2011 |
What descends from it? (27)
See all 275 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212904 | SeaSpine WaveForm C Interbody System | 2021 | 15 |
| K213420 | WaveForm L System, WaveForm TO System, WaveForm TA System | 2022 | 11 |
| K213359 | SeaSpine WaveForm, C Interbody System | 2021 | 7 |
| K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers | 2021 | 3 |
| K192248 | Cortina™ [MAX] Lumbar Cage System | 2019 | 0 |
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 16 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 12 of the 91 ancestors have a recall of any class.
- Of its descendants, K212904 (SeaSpine Orthopedics Corporation, 2021) has gone furthest, with 15 descendants of its own.
- 4 other devices also cite its predicate K121254.
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. 2017, 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 Camber Spine Technologies Ti-Diagon® Oblique TLIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved…
Read the full statement (124 words)
The Camber Spine Technologies Ti-Diagon® Oblique TLIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Camber Spine Technologies Ti-Diagon® Oblique TLIF is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.
Camber Spine Technologies Ti-Diagon® Oblique TLIF implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172064: Ti-Diagon Oblique TLIF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172064
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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