510(k) · Cleared
ClearedARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 5, 2017 as substantially equivalent to K162358 (Synthes USA Products, LLC, 2016) and 10 other predicates after a 120-day review. Its family tree reaches back 19 generations to 1984. 1 of the 414 devices in its family, counting itself, has a Class I recall. 109 later devices descend from it.
- Decided
- Oct 5, 2017
- Review
- 120 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 19 generations to K841189 (1984). 304 ancestors in all, the oldest K792352 (1979). 109 later devices descend from it, 5 citing it directly. 1 of the 414 devices in this family, counting this one, has a Class I recall.
- 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 backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- 1 generation backK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
- This deviceK171689 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2017
- Descendant · cites it directly · 108 of its ownK190959 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 2 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 81 of its ownK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- Descendant · cites it directly · 79 of its ownK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- Descendant · 3 generations on · 75 of its ownK211258 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System…Medtronic Sofamor Danek USA, Inc. · 2021
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 backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- 1 generation backK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
- This deviceK171689 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2017
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 5 of 109 · See all- K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2019 · cites it directly108descendants
- K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 2 generations on102descendants
- K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc. · 2020 · 3 generations on81descendants
- K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020 · cites it directly79descendants
- K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc. · 2021 · 3 generations on75descendants
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 | K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | 2015 | — |
| −1 | K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System | Synthes USA Products, LLC | 2016 | — |
| 0 (this device) | K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| +1 | K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +2 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| +3 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| +1 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| +3 | K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System… | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 17 | 0 |
| 2004 | 26 | 0 |
| 2005 | 17 | 0 |
| 2006 | 11 | 0 |
| 2007 | 16 | 0 |
| 2008 | 43 | 1 |
| 2009 | 25 | 0 |
| 2010 | 21 | 0 |
| 2011 | 25 | 0 |
| 2012 | 16 | 0 |
| 2013 | 15 | 0 |
| 2014 | 15 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 8 | 0 |
| 2022 | 13 | 0 |
| 2023 | 10 | 0 |
| 2024 | 23 | 0 |
| 2025 | 23 | 0 |
| 2026 | 25 | 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? (11)
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 |
|---|---|---|---|
| * | K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSummary page 5…3080) Regulatory Class Class II Product Code MAX Predicate 1 (Primary) – DePuy Synthes T-PAL Spacer System K162358 SE 11/01/2016 Predicate 2 CRESCENT® Ti K122037 SE 03/22/2013… | 2016 |
| * | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Summary page 5…mary) – DePuy Synthes T-PAL Spacer System K162358 SE 11/01/2016 Predicate 2 CRESCENT® Ti K122037 SE 03/22/2013 Predicate 3 K2M CASCADIA™ TL Interbody System K160547 SE 03/24/2… | 2013 |
| * | K160547 | Cascadia Interbody SystemSummary page 5…icate 2 CRESCENT® Ti K122037 SE 03/22/2013 Predicate 3 K2M CASCADIA™ TL Interbody System K160547 SE 03/24/2016 Predicate 4 NuVasive® Brigade® Hyperlordotic System K123045 SE 0… | 2016 |
| * | K123045 | Brigade Standalone SystemSummary page 5…terbody System K160547 SE 03/24/2016 Predicate 4 NuVasive® Brigade® Hyperlordotic System K123045 SE 04/16/2013 Predicate Devices Predicate 5 CLYDESDALE® Spinal System K151128 SE 08/06/2015… | 2013 |
| * | K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal SystemSummary page 5…rigade® Hyperlordotic System K123045 SE 04/16/2013 Predicate Devices Predicate 5 CLYDESDALE® Spinal System K151128 SE 08/06/2015 Predicate 6 WAVE-D Spinal System K121333 SE 06/29/2012… | 2015 |
| * | K121333 | Wave D CageSummary page 5…icate 5 CLYDESDALE® Spinal System K151128 SE 08/06/2015 Predicate 6 WAVE-D Spinal System K121333 SE 06/29/2012 Predicate 7 CAPSTONE® PEEK K073291 SE 04/24/2008, K123027 SE 07/… | 2012 |
| * | K073291 | Capstone Spinal SystemSummary page 5…Predicate 6 WAVE-D Spinal System K121333 SE 06/29/2012 Predicate 7 CAPSTONE® PEEK K073291 SE 04/24/2008, K123027 SE 07/25/2013 Predicate 8 CAPSTONE® PTC K133205 SE 03/1… | 2008 |
| * | K123027 | Capstone (R) Spinal SystemSummary page 5…-D Spinal System K121333 SE 06/29/2012 Predicate 7 CAPSTONE® PEEK K073291 SE 04/24/2008, K123027 SE 07/25/2013 Predicate 8 CAPSTONE® PTC K133205 SE 03/13/2014… | 2013 |
| * | K133205 | Capstone PTC Spinal System, Clydesdale PTC Spinal SystemSummary page 5…7 CAPSTONE® PEEK K073291 SE 04/24/2008, K123027 SE 07/25/2013 Predicate 8 CAPSTONE® PTC K133205 SE 03/13/2014 Predicate 9 CRESCENT® Spinal System… | 2014 |
| * | K094025 | Crescent Spinal SystemSummary page 6…SCENT® Spinal System K171689 - Page 2 of 6 K094025 SE 04/26/2010 Predicate 10 LOOP® Spinal System K121332 SE 06/29/2012… | 2010 |
| * | K121332 | Loop CageSummary page 6…K171689 - Page 2 of 6 K094025 SE 04/26/2010 Predicate 10 LOOP® Spinal System K121332 SE 06/29/2012 The ARTiC-L™ and ARTiC-XL™ 3D Ti Spinal Systems with TiONIC™ Technology… | 2012 |
What descends from it? (109)
See all 1095 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with… | 2019 | 108 |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | 2020 | 79 |
| K210425 | Catalyft PL Expandable Interbody System | 2021 | 56 |
| K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | 2022 | 49 |
| K261020 | Symmetrix™ L Spinal System | 2026 | 0 |
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 33 years and passes through 13 companies; a new generation was cleared every 11 months on median.
- 32 of the 304 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K190959 (Medtronic Sofamor Danek USA, Inc., 2019) has gone furthest, with 108 descendants of its own.
- 4 other devices also cite its predicate K162358.
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 ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, ARTiC-L™ 3D Ti Spinal System can be used in patients diagnosed with spinal…
Read the full statement (274 words)
The ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, ARTiC-L™ 3D Ti Spinal System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.
The ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, ARTiC-XL™ 3D Ti Spinal System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171689: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171689
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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