510(k) · Cleared
ClearedFortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 20, 2019 as substantially equivalent to K190498 (Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc., 2019) and 1 other predicate after an 84-day review. Its family tree reaches back 22 generations to 1984. 5 later devices descend from it.
- Decided
- Dec 20, 2019
- Review
- 84 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 22 generations to K841189 (1984). 181 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK170643 Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics · 2017
- 2 generations backK172343 Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc. · 2017
- 1 generation backK190498 Fortilink® IBF System with TETRAfuse®3D Technology, include the…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019
- This deviceK192718 Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK201453 Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020
- Descendant · 2 generations on · 3 of its ownK242260 aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical…Carlsmed, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK250827 aprevo® anterior lumbar interbody fusion device; aprevo® lateral…Carlsmed, Inc. · 2025
- Descendant · 4 generations on · 1 of its ownK252894 aprevo® cervical interbody systemCarlsmed, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK260385 aprevo® anterior and lateral lumbar interbody system; aprevo®…Carlsmed, Inc. · 2026
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 4 generations backK160906 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody…Spineology, Inc. · 2016
- 3 generations backK170643 Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics · 2017
- 2 generations backK172343 Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc. · 2017
- 1 generation backK190498 Fortilink® IBF System with TETRAfuse®3D Technology, include the…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019
- This deviceK192718 Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020 · cites it directly4descendants
- K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc. · 2024 · 2 generations on3descendants
- K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc. · 2025 · 3 generations on2descendants
- K252894aprevo® cervical interbody systemCarlsmed, Inc. · 2026 · 4 generations on1descendant
- K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| −4 | K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion… | Spineology, Inc. | 2016 | — |
| −3 | K170643 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | Rti Surgical, Inc. Dba Rti Biologics | 2017 | — |
| −2 | K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology | Rti Surgical, Inc. | 2017 | — |
| −1 | K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following… | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2019 | — |
| 0 (this device) | K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2019 | — |
| +1 | K201453 | Fortilink Cages with TiPlus Technology | Paradigm Spine GmbH | 2020 | — |
| +2 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024 | — |
| +3 | K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar… | Carlsmed, Inc. | 2025 | — |
| +4 | K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026 | — |
| +4 | K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and… | Carlsmed, Inc. | 2026 | — |
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 | 10 | 0 |
| 2004 | 15 | 0 |
| 2005 | 13 | 0 |
| 2006 | 2 | 0 |
| 2007 | 9 | 0 |
| 2008 | 25 | 0 |
| 2009 | 18 | 0 |
| 2010 | 7 | 0 |
| 2011 | 10 | 0 |
| 2012 | 6 | 0 |
| 2013 | 8 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Summary page 5…MAX (Intervertebral fusion device with bone graft, lumbar) Predicate Devices: Primary - Fortilink®-L Interbody Fusion Device (IBF) with TETRAfuse® 3D Technology (K190498) Additional - Fortilink®-C Interbody Fusion Device (IBF) with TETRAfuse® 3D Technology (K163673) Purpose The purpose of this subm… | 2019 |
| * | K163673 | Fortilink™-C with TETRAfuse™ 3D TechnologySummary page 5…Fortilink®-L Interbody Fusion Device (IBF) with TETRAfuse® 3D Technology (K190498) Additional - Fortilink®-C Interbody Fusion Device (IBF) with TETRAfuse® 3D Technology (K163673) Purpose The purpose of this submission is to obtain clearance for the Fortilink®-A Interbody Fusion Device (IBF) with TETRAfuse®… | 2017 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201453 | Fortilink Cages with TiPlus Technology | 2020 | 4 |
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 35 years and passes through 16 companies; a new generation was cleared every 9 months on median.
- 18 of the 181 ancestors have a recall of any class.
- Of its descendants, K201453 (Paradigm Spine GmbH, 2020) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K190498.
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. 2019, 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 the Fortilink-A is used as a lumbar interbody fusion (IBF) implant, it is indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This IBF device is used to facilitate…
Read the full statement (423 words)
When the Fortilink-A is used as a lumbar interbody fusion (IBF) implant, it is indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This IBF device is used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF device is intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of non-operative treatment prior to treatment with an interbody fusion device. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
When Fortilink-C is used as cervical interbody fusion (IBF) implants, these devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from C2-C3 to C7-T1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an interbody fusion device.
When Fortilink-TS and Fortilink-L are used as lumbar interbody fusion (IBF) implants, these devices are indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of non-operative treatment prior to treatment with an interbody fusion device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192718: Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192718
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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