510(k) · Cleared
ClearedAnteralign Spinal System with Titan nanoLOCK Surface Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 12, 2022 as substantially equivalent to K212524 (Medtronic Sofamor Danek USA, Inc., 2021) and 6 other predicates after a 111-day review. Its family tree reaches back 29 generations to 1984. 1 of the 647 devices in its family, counting itself, has a Class I recall. 49 later devices descend from it.
- Decided
- Apr 12, 2022
- Review
- 111 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 29 generations to K841189 (1984). 597 ancestors in all, the oldest K792352 (1979). 49 later devices descend from it, 4 citing it directly. 1 of the 647 devices in this family, counting this one, has a Class I recall.
- Root · 29 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations between
- 3 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 2 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 1 generation backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- This deviceK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- Descendant · cites it directly · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- Descendant · cites it directly · 17 of its ownK223494 CD Horizon Spinal SystemMedtronic · 2023
- Descendant · 2 generations on · 7 of its ownK240368 E3D™-A Interbody SystemEvolution Spine · 2024
- Descendant · 2 generations on · 7 of its ownK232097 IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 7 of its ownK231438 Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. · 2023
Show all 29 generations
- Root · 29 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 28 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 27 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 26 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 25 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 24 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 23 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 22 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 21 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 20 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 19 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 18 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 17 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 16 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 15 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 14 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 13 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 12 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 11 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 10 generations backK160955 Tritanium® PL CageStryker · 2016
- 9 generations backK162262 Tritanium® PL CageStryker · 2016
- 8 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 7 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 6 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 5 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 4 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 3 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 2 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 1 generation backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- This deviceK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 5 of 49 · See all- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · cites it directly28descendants
- K223494CD Horizon Spinal SystemMedtronic · 2023 · cites it directly17descendants
- K240368E3D™-A Interbody SystemEvolution Spine · 2024 · 2 generations on7descendants
- K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. · 2023 · 2 generations on7descendants
- K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. · 2023 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −29 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −28 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −27 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −26 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −25 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −24 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −23 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −22 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −21 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −20 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −19 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −18 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −17 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −16 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −15 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −14 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −13 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −12 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −11 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −10 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −9 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −8 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −7 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −6 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −5 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −4 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −3 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −2 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −1 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| 0 (this device) | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| +1 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| +1 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
| +2 | K240368 | E3D™-A Interbody System | Evolution Spine | 2024 | — |
| +2 | K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | 2023 | 1 |
| +2 | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 9 | 0 |
| 2001 | 14 | 0 |
| 2002 | 16 | 0 |
| 2003 | 22 | 0 |
| 2004 | 41 | 0 |
| 2005 | 33 | 0 |
| 2006 | 17 | 0 |
| 2007 | 19 | 0 |
| 2008 | 54 | 1 |
| 2009 | 39 | 0 |
| 2010 | 28 | 0 |
| 2011 | 45 | 0 |
| 2012 | 30 | 0 |
| 2013 | 34 | 0 |
| 2014 | 35 | 0 |
| 2015 | 32 | 0 |
| 2016 | 20 | 0 |
| 2017 | 19 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 12 | 0 |
| 2025 | 13 | 0 |
| 2026 | 17 | 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? (7)
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 |
|---|---|---|---|
| * | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface TechnologySummary page 5…Class II III. Predicate Devices: Primary Predicate: Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology (K212524, S.E. 12/08/2021) Additional Predicate 2: The Endoskeleton™ TAS Interbody… | 2021 |
| * | K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Summary page 5…hnology (K212524, S.E. 12/08/2021) Additional Predicate 2: The Endoskeleton™ TAS Interbody System (K211258, S.E. 05/26/2021) Additional Predicate 3: The Endoskeleton™ TAS Hyperlordotic… | 2021 |
| * | K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Summary page 6…Page 2 of 8 Additional Predicate 4: Artic-XL 3D Ti Spinal System with Tionic Technology (K171689, S.E. 10/05/17) Additional Predicate 5: Capstone PEEK (K073291, S.E. 04/24/2008, K1230… | 2017 |
| * | K073291 | Capstone Spinal SystemSummary page 6…edicate 4: Artic-XL 3D Ti Spinal System with Tionic Technology (K171689, S.E. 10/05/17) Additional Predicate 5: Capstone PEEK (K073291, S.E. 04/24/2008, K123027, S.E. 07/25/2013) Additional Predicate 6: LT Cage™ PEEK Lumb… | 2008 |
| * | K123027 | Capstone (R) Spinal SystemSummary page 6…onic Technology (K171689, S.E. 10/05/17) Additional Predicate 5: Capstone PEEK (K073291, S.E. 04/24/2008, K123027, S.E. 07/25/2013) Additional Predicate 6: LT Cage™ PEEK Lumbar Tapered Fusion Device (… | 2013 |
| * | P970015 | Inter Fix Threaded Fusion DeviceSummary page 6…04/24/2008, K123027, S.E. 07/25/2013) Additional Predicate 6: LT Cage™ PEEK Lumbar Tapered Fusion Device (P9700155022, S.E. 09/10/2003) Additional Predicate 7: Crescent PEEK, (K094025, S.E. 04/26/2010… | 1999 |
| * | K094025 | Crescent Spinal SystemSummary page 6…Predicate 6: LT Cage™ PEEK Lumbar Tapered Fusion Device (P9700155022, S.E. 09/10/2003) Additional Predicate 7: Crescent PEEK, (K094025, S.E. 04/26/2010) Additional Predicate 8: Capstone Spinal System PEEK,… | 2010 |
What descends from it? (49)
See all 494 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 38 years and passes through 16 companies; a new generation was cleared every 8 months on median.
- 70 of the 597 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K222028 (Alphatec Spine, 2022) has gone furthest, with 28 descendants of its own.
- 3 other devices also cite its predicate K212524.
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. 2022, 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?
Anteralign Spinal System with Titan nanoLOCK ™ Surface Technology System interbody cages with macro-, micro-, and nano- roughened surface textured features are intended to be used in spinal fusion procedures on skeletally mature patients with symptomatic Degenerative Disc Disease (DDD, defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis, at…
Read the full statement (432 words)
Anteralign Spinal System with Titan nanoLOCK ™ Surface Technology System interbody cages with macro-, micro-, and nano- roughened surface textured features are intended to be used in spinal fusion procedures on skeletally mature patients with symptomatic Degenerative Disc Disease (DDD, defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis, at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should have had six months of nonoperative treatment prior to treatment with this device. Additionally, the Anteralign Spinal System with Titan nanoLOCK ™ Surface Technology can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Anteralign Spinal System with Titan nanoLOCK ™ Surface Technology is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or a combination thereof.
The Anteralign TL lnterbody must be used with a posterior supplemental internal spinal fixation cleared for use in the lumbar spine.
Miniplate and bone screw components are provided as an option for anti-migration for the TL interbody for the lumbosacral levels oblique or lateral above the bifurcation (L2-L5) of the vascular structures. Indications and contraindications of spinal instrumentation systems should be understood by the surgeon
The Anteralign Spinal System with Titan nanoLOCK ™ Surface Technology TL interbody may be implanted via a minimally invasive OLIF or minimally invasive or open DLIF approach.
The Anteralign ™ LS interbody cage may be used as a stand-alone device or in conjunction with supplemental fixation. The Anteralign LS ™ interbody fusion Device may be inserted via minimally invasive or open anterior or oblique approach at one or two contiguous levels from L2 to S1. These approaches include anterior and oblique. When used as a stand-alone device, the Anteralign ™ LS cage must be used with 3 screws with devices that have standard lordosis (S16 degrees). If the physician chooses to use less than 3 screws or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g., posterior fixation) must be used. Additionally, cages with lordosis angles greater than 16 ° are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K214010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214010: Anteralign Spinal System with Titan nanoLOCK Surface Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214010
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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