510(k) · Cleared
ClearedFortilink Cages with TiPlus Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paradigm Spine GmbH · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 7, 2020 as substantially equivalent to K172888 (Eit Emerging Implant Technologies GmbH, 2017) and 4 other predicates after a 128-day review. Its family tree reaches back 23 generations to 1984. 1 of the 347 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Oct 7, 2020
- Review
- 128 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 23 generations to K841189 (1984). 342 ancestors in all, the oldest K792352 (1979). 4 later devices descend from it, 1 citing it directly. 1 of the 347 devices in this family, counting this one, has a Class I recall.
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations between
- 3 generations backK172343 Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc. · 2017
- 2 generations backK190498 Fortilink® IBF System with TETRAfuse®3D Technology, include the…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019
- 1 generation backK192718 Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019
- This deviceK201453 Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020
- Descendant · cites it directly · 3 of its ownK242260 aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical…Carlsmed, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK250827 aprevo® anterior lumbar interbody fusion device; aprevo® lateral…Carlsmed, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK252894 aprevo® cervical interbody systemCarlsmed, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK260385 aprevo® anterior and lateral lumbar interbody system; aprevo®…Carlsmed, Inc. · 2026
Show all 23 generations
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 21 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 20 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 17 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 16 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 13 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 12 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 11 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 10 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 9 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 8 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 7 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 6 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 5 generations backK160906 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody…Spineology, Inc. · 2016
- 4 generations backK170643 Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics · 2017
- 3 generations backK172343 Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc. · 2017
- 2 generations backK190498 Fortilink® IBF System with TETRAfuse®3D Technology, include the…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019
- 1 generation backK192718 Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019
- This deviceK201453 Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 4 of 4 · See all- K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc. · 2024 · cites it directly3descendants
- K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc. · 2025 · 2 generations on2descendants
- K252894aprevo® cervical interbody systemCarlsmed, Inc. · 2026 · 3 generations on1descendant
- K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −22 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −21 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −20 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −17 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −16 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −13 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −12 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −11 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −10 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −9 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −8 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −7 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −6 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| −5 | K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion… | Spineology, Inc. | 2016 | — |
| −4 | K170643 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | Rti Surgical, Inc. Dba Rti Biologics | 2017 | — |
| −3 | 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 | — |
| −1 | K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2019 | — |
| 0 (this device) | K201453 | Fortilink Cages with TiPlus Technology | Paradigm Spine GmbH | 2020 | — |
| +1 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024 | — |
| +2 | K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar… | Carlsmed, Inc. | 2025 | — |
| +3 | K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026 | — |
| +3 | 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 |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 12 | 0 |
| 2002 | 10 | 0 |
| 2003 | 18 | 0 |
| 2004 | 27 | 0 |
| 2005 | 20 | 0 |
| 2006 | 11 | 0 |
| 2007 | 15 | 0 |
| 2008 | 43 | 1 |
| 2009 | 36 | 0 |
| 2010 | 19 | 0 |
| 2011 | 24 | 0 |
| 2012 | 18 | 0 |
| 2013 | 13 | 0 |
| 2014 | 15 | 0 |
| 2015 | 10 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Summary page 13…Titanium® Cervical Cages, EIT Implant Cellular Titanium® PLIF Cages, EIT Cellular K172888 Technologies Titanium® TLIF Cages, EIT Cellular GmbH Titanium® ALIF Cages Additional Predi… | 2017 |
| * | K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologySummary page 13…Cages with TiPlus Technology are additional substantially equivalent to the Fortilink® Interbody Fusion Device (IFB) with TETRAfuse® 3D Technology (RTI Surgical, Inc.) (K192718), Unison®-C Anterior Cervical Fixation System (RTI Surgical, Inc.) (K170830), EIT Cellular Titanium® Lumbar Cage LLIF (EIT Emergi… | 2019 |
| * | K170830 | Unison-C Anterior Cervical Fixation SystemSummary page 13…Fortilink® Interbody Fusion Device (IFB) with TETRAfuse® 3D Technology (RTI Surgical, Inc.) (K192718), Unison®-C Anterior Cervical Fixation System (RTI Surgical, Inc.) (K170830), EIT Cellular Titanium® Lumbar Cage LLIF (EIT Emerging Implant Technologies GmbH) (K181644), Centinel STALIF M FLX™ (Centinel Sp… | 2017 |
| * | K181644 | EIT Cellular Titanium® Lumbar Cage LLIFSummary page 13…(K192718), Unison®-C Anterior Cervical Fixation System (RTI Surgical, Inc.) (K170830), EIT Cellular Titanium® Lumbar Cage LLIF (EIT Emerging Implant Technologies GmbH) (K181644), Centinel STALIF M FLX™ (Centinel Spine, Inc.) (K173347), HEDRON™ Cervical Spacers (Globus Medical Inc.), Ax™ Stand-Alone ALIF S… | 2018 |
| * | K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Summary page 13…RTI Surgical, Inc.) (K170830), EIT Cellular Titanium® Lumbar Cage LLIF (EIT Emerging Implant Technologies GmbH) (K181644), Centinel STALIF M FLX™ (Centinel Spine, Inc.) (K173347), HEDRON™ Cervical Spacers (Globus Medical Inc.), Ax™ Stand-Alone ALIF System (Innovasis, Inc.), and EVOL® Spinal Interbody Syste… | 2018 |
| * | — | HEDRON™ Cervical Spacers Named without a submission number | |
| * | — | Ax™ Stand-Alone ALIF System Named without a submission number | |
| * | — | EVOL® Spinal Interbody System Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | 2024 | 3 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 17 companies; a new generation was cleared every 9 months on median.
- 38 of the 342 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K242260 (Carlsmed, Inc., 2024) has gone furthest, with 3 descendants of its own.
- 12 other devices also cite its predicate K172888.
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. 2020, 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 Fortilink-A Ti is indicated for anterior interbody fusion (IBF) 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 L2 to…
Read the full statement (981 words)
The Fortilink-A Ti is indicated for anterior interbody fusion (IBF) 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 L2 to 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 FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six 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 FDA cleared supplemental fixation.
The Fortilink-C Ti is intended for spinal fusion procedures at one or more levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
This device is intended to be used with an FDA-cleared supplemental fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.
The Fortilink-L Ti is indicated for lateral interbody fusion (IBF) 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 L2 to 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 FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment prior to treatment with an interbody fusion device.
The Fortilink-SA Ti is indicated for stand-alone anterior lumbar interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is implanted via an anterior approach. Implants must be used with three of the provided bone screws. This system is to be used in patients who have had six months of non-operative treatment.
The Fortilink-SA Ti with lordotic angles greater than or equal to 20 degrees requires the use of FDA cleared supplemental fixation in addition to the screws intrinsic to the interbody spacer.
The Fortilink-SC Ti is intended for stand-alone anterior cervical interbody fusion procedures at one or two levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system is to be used in patients who have had six weeks of non-operative treatment.
The Fortilink-TC Ti is indicated for transforaminal interbody fusion (IBF) 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 L2 to 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 FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment prior to treatment with an interbody fusion device.
The Fortilink-TS Ti is indicated for transforaminal and posterior interbody fusion (IBF) 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 L2 to 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 FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six 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/K201453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201453: Fortilink Cages with TiPlus Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201453
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