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, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 8, 2021 as substantially equivalent to K211258 (Medtronic Sofamor Danek USA, Inc., 2021) and 10 other predicates after a 119-day review. Its family tree reaches back 28 generations to 1984. 1 of the 652 devices in its family, counting itself, has a Class I recall. 55 later devices descend from it.
- Decided
- Dec 8, 2021
- Review
- 119 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 28 generations to K841189 (1984). 596 ancestors in all, the oldest K792352 (1979). 55 later devices descend from it, 4 citing it directly. 1 of the 652 devices in this family, counting this one, has a Class I recall.
- Root · 28 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations between
- 3 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 2 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 1 generation backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- This deviceK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- Descendant · cites it directly · 49 of its ownK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- Descendant · 2 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- Descendant · 2 generations on · 17 of its ownK223494 CD Horizon Spinal SystemMedtronic · 2023
- Descendant · 3 generations on · 7 of its ownK240368 E3D™-A Interbody SystemEvolution Spine · 2024
- Descendant · 3 generations on · 7 of its ownK232097 IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. · 2023 · Recalled
Show all 28 generations
- Root · 28 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 27 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 26 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 25 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 24 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 23 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 22 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 21 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 20 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 19 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 18 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 17 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 16 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 15 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 14 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 13 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 12 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 11 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 10 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 9 generations backK160955 Tritanium® PL CageStryker · 2016
- 8 generations backK162262 Tritanium® PL CageStryker · 2016
- 7 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 6 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 5 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 4 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 3 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 2 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 1 generation backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- This deviceK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 5 of 55 · See all- K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022 · cites it directly49descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 2 generations on28descendants
- K223494CD Horizon Spinal SystemMedtronic · 2023 · 2 generations on17descendants
- K240368E3D™-A Interbody SystemEvolution Spine · 2024 · 3 generations on7descendants
- K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. · 2023 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −28 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −27 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −26 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −25 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −24 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −23 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −22 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −21 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −20 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −19 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −18 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −17 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −16 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −15 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −14 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −13 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −12 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −11 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −10 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −9 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −8 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −7 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −6 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −5 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −4 | 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 | — |
| −2 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −1 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| 0 (this device) | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +1 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| +2 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| +2 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
| +3 | K240368 | E3D™-A Interbody System | Evolution Spine | 2024 | — |
| +3 | K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | 2023 | 1 |
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 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 12 | 0 |
| 2025 | 14 | 0 |
| 2026 | 18 | 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 |
|---|---|---|---|
| * | K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Summary page 5…de MAX, OVD, OLO Predicate Devices Interbody Primary Predicate - Endoskeleton™ TL Hyperlordotic Interbody System (K211258, S.E. 05/26/2021) Additional Predicate 2 - Endoskeleton™ TL Interbody System (K21125… | 2021 |
| * | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface TechnologySummary page 5…(K211258, S.E. 05/26/2021) Additional Predicate 3 - Adaptix ™ Interbody System with Titan nanoLOCK™ Surface Technology (K201267, SE 07/08/2021) Additional Predicate 4 - Clydesdale ™ Spinal System (K151128, S.E. 0… | 2020 |
| * | K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal SystemSummary page 5…System with Titan nanoLOCK™ Surface Technology (K201267, SE 07/08/2021) Additional Predicate 4 - Clydesdale ™ Spinal System (K151128, S.E. 08/06/2015; K132897, S.E. 12/11/2013; K133577, S.E. 09/26/2014) Additional Pre… | 2015 |
| * | K132897 | Clydesdale Spinal SystemSummary page 5…™ Surface Technology (K201267, SE 07/08/2021) Additional Predicate 4 - Clydesdale ™ Spinal System (K151128, S.E. 08/06/2015; K132897, S.E. 12/11/2013; K133577, S.E. 09/26/2014) Additional Predicate 5 - Capstone™ Spinal System… | 2013 |
| * | K133577 | Clydesdale (R) Spinal SystemSummary page 5…267, SE 07/08/2021) Additional Predicate 4 - Clydesdale ™ Spinal System (K151128, S.E. 08/06/2015; K132897, S.E. 12/11/2013; K133577, S.E. 09/26/2014) Additional Predicate 5 - Capstone™ Spinal System (K073291, S.E. 04… | 2014 |
| * | K073291 | Capstone Spinal SystemSummary page 5…08/06/2015; K132897, S.E. 12/11/2013; K133577, S.E. 09/26/2014) Additional Predicate 5 - Capstone™ Spinal System (K073291, S.E. 04/24/08; K123047, S.E. 07/25/13) Additional Predicate 6 – Sovereign™ Spinal System… | 2008 |
| * | K123027 | Capstone (R) Spinal System Our reading of the summary gave K123047, FDA’s number for Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line… (Bracco Diagnostic, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Capstone™ Spinal System”. | 2013 |
| * | K091813 | Intrepid Spinal SystemSummary page 6…K212524 Page 2 of 6 (K091813, S.E 11/17/09) Additional Predicate 9 – Artic-XL 3D Ti Spinal System with TIONIC… | 2009 |
| * | K152277 | PIVOX (tm) Oblique Lateral Spinal SystemSummary page 6…Mini Plates and Screws Additional Predicate 7- Pivox™ Oblique Lateral Spinal System (K152277, S.E 11/13/15) Medtronic Navigated Manual Reusable Instruments for Use with… | 2015 |
| * | K210425 | Catalyft PL Expandable Interbody SystemSummary page 6…Station™ System Additional Predicate 8- Catalyft™ PL Expandable Interbody System Navigated Trials and Inserter- (K210425, S. E. 5/24/21) Primary Predicate- Endoskeleton™ TL Hyperlordotic Interbody System… | 2021 |
| * | K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Summary page 6…S.E 11/17/09) Additional Predicate 9 – Artic-XL 3D Ti Spinal System with TIONIC ` Technology (K190959 – S.E. 7/3/19) Mini Plates and Screws Additional Predicate 7- Pivox™ Ob… | 2019 |
What descends from it? (55)
See all 554 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | 2022 | 49 |
| K221180 | Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments | 2022 | 2 |
| K214011 | Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal… | 2022 | 1 |
| 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 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 15 companies; a new generation was cleared every 9 months on median.
- 70 of the 596 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K214010 (Medtronic Sofamor Danek USA, 2022) has gone furthest, with 49 descendants of its own.
- 7 other devices also cite its predicate K211258.
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. 2021, 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 (382 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. These implants may be implanted via a minimally invasive OLIF or minimally invasive or open DLIF approach. The Anteralign Spinal System 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 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.
Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
Navigated surgical instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses described on the label and the instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212524: 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/K212524
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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