510(k) · Cleared
ClearedInterbody Fusion (IBF)/Vertebral Body Replacement (VBR) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rti Surgical, Inc. Dba Rti Biologics · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 14, 2017 as substantially equivalent to K150521 (Rti Surgical, Inc. Dba Rti Biologics, 2015) and 7 other predicates after a 43-day review. Its family tree reaches back 19 generations to 1984. 11 later devices descend from it.
- Decided
- Apr 14, 2017
- Review
- 43 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 19 generations to K841189 (1984). 169 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 1 generation backK160906 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody…Spineology, Inc. · 2016
- This deviceK170643 Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics · 2017
- Descendant · cites it directly · 10 of its ownK172343 Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc. · 2017
- Descendant · 2 generations on · 7 of its ownK190498 Fortilink® IBF System with TETRAfuse®3D Technology, include the…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019
- Descendant · 3 generations on · 5 of its ownK192718 Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019
- Descendant · 4 generations on · 4 of its ownK201453 Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020
- Descendant · 5 generations on · 3 of its ownK242260 aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical…Carlsmed, Inc. · 2024
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 1 generation backK160906 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody…Spineology, Inc. · 2016
- This deviceK170643 Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc. · 2017 · cites it directly10descendants
- K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019 · 2 generations on7descendants
- K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019 · 3 generations on5descendants
- K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020 · 4 generations on4descendants
- K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc. · 2024 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −8 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −6 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −5 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −4 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −3 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −2 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| −1 | K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion… | Spineology, Inc. | 2016 | — |
| 0 (this device) | K170643 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | Rti Surgical, Inc. Dba Rti Biologics | 2017 | — |
| +1 | K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology | Rti Surgical, Inc. | 2017 | — |
| +2 | K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following… | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2019 | — |
| +3 | K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2019 | — |
| +4 | K201453 | Fortilink Cages with TiPlus Technology | Paradigm Spine GmbH | 2020 | — |
| +5 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 9 | 0 |
| 2004 | 15 | 0 |
| 2005 | 12 | 0 |
| 2006 | 2 | 0 |
| 2007 | 8 | 0 |
| 2008 | 24 | 0 |
| 2009 | 17 | 0 |
| 2010 | 7 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (8)
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 |
|---|---|---|---|
| * | K150521 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemSummary page 6…P Panel/ Branch: Orthopedic and Rehabilitation Devices Panel; Panel Code 87 Restorative Devices Branch Primary Pioneer IBF/VBR System K150521 Predicate Device Additional Pioneer IBF/VBR System (K043206, K061151, K073177, K112496, Predicate K133623, K133… | 2015 |
| * | K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Summary page 6…nel Code 87 Restorative Devices Branch Primary Pioneer IBF/VBR System K150521 Predicate Device Additional Pioneer IBF/VBR System (K043206, K061151, K073177, K112496, Predicate K133623, K133455, and K150521) Devices: Rampart™ O, Rampart™ T… | 2005 |
| * | K061151 | Pioneer Vertebral Spacer (Vertebral Spacer)Summary page 6…87 Restorative Devices Branch Primary Pioneer IBF/VBR System K150521 Predicate Device Additional Pioneer IBF/VBR System (K043206, K061151, K073177, K112496, Predicate K133623, K133455, and K150521) Devices: Rampart™ O, Rampart™ T and Rampa… | 2006 |
| * | K073177 | Pioneer Intervertebral Fusion Device SystemSummary page 6…Restorative Devices Branch Primary Pioneer IBF/VBR System K150521 Predicate Device Additional Pioneer IBF/VBR System (K043206, K061151, K073177, K112496, Predicate K133623, K133455, and K150521) Devices: Rampart™ O, Rampart™ T and Rampart™ A Lum… | 2008 |
| * | K112496 | Pioneer Crossfuse II Ibf/VBR SystemSummary page 6…Restorative Devices Branch Primary Pioneer IBF/VBR System K150521 Predicate Device Additional Pioneer IBF/VBR System (K043206, K061151, K073177, K112496, Predicate K133623, K133455, and K150521) Devices: Rampart™ O, Rampart™ T and Rampart™ A Lumbar Inter… | 2011 |
| * | K133623 | C-PLUSSummary page 6…ch Primary Pioneer IBF/VBR System K150521 Predicate Device Additional Pioneer IBF/VBR System (K043206, K061151, K073177, K112496, Predicate K133623, K133455, and K150521) Devices: Rampart™ O, Rampart™ T and Rampart™ A Lumbar Interbody Fusion… | 2014 |
| * | K133455 | Crossfuse II Coronal Taper, Crossfuse II HyperlordoticSummary page 6…ry Pioneer IBF/VBR System K150521 Predicate Device Additional Pioneer IBF/VBR System (K043206, K061151, K073177, K112496, Predicate K133623, K133455, and K150521) Devices: Rampart™ O, Rampart™ T and Rampart™ A Lumbar Interbody Fusion Device… | 2014 |
| * | K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Summary page 6…6, Predicate K133623, K133455, and K150521) Devices: Rampart™ O, Rampart™ T and Rampart™ A Lumbar Interbody Fusion Device (K160906) Description: The system includes implantable devices manufactured from PEEK with tantalum or titanium a… | 2016 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology | 2017 | 10 |
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 33 years and passes through 14 companies; a new generation was cleared every 9 months on median.
- 17 of the 169 ancestors have a recall of any class.
- Of its descendants, K172343 (Rti Surgical, Inc., 2017) has gone furthest, with 10 descendants of its own.
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?
When used as a cervical intervertebral body fusion implant, the Interbody Fusion (IBF)/ Vertebral Body Replacement (VBR) System (“IBF/VBR System”) is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2 to C3 intervertebral body space to the C7 to T1 intervertebral body space, for the treatment of cervical disc disease (defined as neck pain…
Read the full statement (440 words)
When used as a cervical intervertebral body fusion implant, the Interbody Fusion (IBF)/ Vertebral Body Replacement (VBR) System (“IBF/VBR System”) is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2 to C3 intervertebral body space to the C7 to T1 intervertebral body space, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Cervical IBFs are to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level.
When used as a lumbar intervertebral body fusion implant, the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System (“IBF/VBR System”) is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1 intervertebral body space, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level.
When used as a vertebral body replacement (VBR) implant, the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System (“IBF/VBR System”) is intended for use in the thoracolumbar spine, from T1 to L5, for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system is intended to be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1 to L5). Additionally, the VBR implant is intended to be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170643: Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170643
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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