510(k) · Cleared
ClearedIdentiTi™ II Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 4, 2024 as substantially equivalent to K203714 (Nu Vasive, Incorporated, 2021) and 8 other predicates after a 56-day review. Its family tree reaches back 32 generations to 1984. 2 of the 1,409 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Oct 4, 2024
- Review
- 56 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 32 generations to K841189 (1984). 1,404 ancestors in all, the oldest K761228 (1976). 4 later devices descend from it, 4 citing it directly. 2 of the 1,409 devices in this family, counting this one, have a Class I recall.
- Root · 32 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 28 generations between
- 3 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 2 generations backK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- 1 generation backK223611 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023
- This deviceK242364 IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK261020 Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251575 IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF…Alphatec Spine · 2025
- Descendant · cites it directly · 0 of its ownK251080 IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK251617 X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable…Expanding Innovations, Inc. · 2025
Show all 32 generations
- Root · 32 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 31 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 30 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 29 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 28 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 27 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 26 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 25 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 24 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 23 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 22 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 21 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 20 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 19 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 18 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 17 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 16 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 15 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 14 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 13 generations backK160955 Tritanium® PL CageStryker · 2016
- 12 generations backK162262 Tritanium® PL CageStryker · 2016
- 11 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 10 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 9 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 8 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 7 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 6 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 5 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 4 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 3 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 2 generations backK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- 1 generation backK223611 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023
- This deviceK242364 IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026 · cites it directly0descendants
- K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine · 2025 · cites it directly0descendants
- K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc. · 2025 · cites it directly0descendants
- K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −32 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −31 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −30 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −29 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −28 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −27 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −26 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −25 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −24 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −23 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −22 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −21 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −20 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −19 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −18 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −17 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −16 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −15 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −14 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −13 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −12 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −11 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −10 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −9 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −8 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −7 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −6 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −5 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −4 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −3 | 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 | — |
| −1 | K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023 | — |
| 0 (this device) | K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024 | — |
| +1 | K261020 | Symmetrix™ L Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026 | — |
| +1 | K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone… | Alphatec Spine | 2025 | — |
| +1 | K251080 | IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. | 2025 | — |
| +1 | K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral… | Expanding Innovations, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 4 | 0 |
| 1987 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 6 | 0 |
| 1991 | 1 | 0 |
| 1992 | 11 | 0 |
| 1993 | 9 | 0 |
| 1994 | 17 | 0 |
| 1995 | 24 | 0 |
| 1996 | 27 | 0 |
| 1997 | 25 | 0 |
| 1998 | 38 | 0 |
| 1999 | 32 | 0 |
| 2000 | 42 | 0 |
| 2001 | 53 | 0 |
| 2002 | 47 | 0 |
| 2003 | 56 | 0 |
| 2004 | 74 | 0 |
| 2005 | 69 | 0 |
| 2006 | 55 | 0 |
| 2007 | 51 | 0 |
| 2008 | 94 | 1 |
| 2009 | 74 | 0 |
| 2010 | 67 | 1 |
| 2011 | 84 | 0 |
| 2012 | 54 | 0 |
| 2013 | 58 | 0 |
| 2014 | 55 | 0 |
| 2015 | 54 | 0 |
| 2016 | 52 | 0 |
| 2017 | 45 | 0 |
| 2018 | 25 | 0 |
| 2019 | 19 | 0 |
| 2020 | 17 | 0 |
| 2021 | 11 | 0 |
| 2022 | 7 | 0 |
| 2023 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 3 | 0 |
| 2026 | 1 | 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.
2 devices in this family have 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? (9)
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 |
|---|---|---|---|
| * | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Summary page 5…k) Product Name Product Code Clearance Date NuVasive Thoracolumbar Interbody MAX, MQV, K203714 December 23, 2021 Systems… | 2021 |
| * | K223611 | Calibrate LTX Interbody SystemSummary page 5…) Product Name Product Code Clearance Date MAX, PHM, K223611 Calibrate™ LTX Interbody System March 29, 2023… | 2023 |
| * | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Summary page 5…March 29, 2023 OVD IdentiTi™ and Transcend™ Interbody MAX, OVD, K222028 October 07, 2022 Systems… | 2022 |
| * | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemSummary page 5…028 October 07, 2022 Systems PHM K231438 Calibrate™ PSX Interbody System MAX July 13, 2023 IdentiTiTM and Transc… | 2023 |
| * | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Summary page 5…PHM K231438 Calibrate™ PSX Interbody System MAX July 13, 2023 IdentiTiTM and TranscendTM Interbody K222973 ODP, OVE September 27, 2022 Systems… | 2022 |
| * | K202587 | ATEC Lateral Interbody SystemSummary page 5…ODP, OVE September 27, 2022 Systems MAX, PHM, K202587 ATEC Lateral Interbody System November 6, 2020… | 2020 |
| * | K182746 | ATEC ALIF and LLIF Spacer SystemSummary page 5…November 6, 2020 OVD MAX, OVD, K182746 ATEC ALIF and LLIF Spacer System November 27, 2018… | 2018 |
| * | K180480 | ATEC Universal Spacer SystemSummary page 5…82746 ATEC ALIF and LLIF Spacer System November 27, 2018 PHM K180480 ATEC Universal Spacer System PHM, MAX May 31, 2018… | 2018 |
| * | K232275 | Invictus® Spinal Fixation SystemSummary page 7…he additional predicates IdentiTi and Transcend Interbody Systems (K222028), Calibrate LTX Interbody System (K223611), and Invictus Spinal Fixation System (K232275). The technological design features of the subject implants were compared to the predicates in intended use, indica… | 2023 |
| † | K240951 | Invictus Robotic Navigation Instruments | 2024 |
| † | K192938 | Invictus™ Spinal Fixation System | 2019 |
| † | K161363 | Arsenal Spinal Fixation System | 2016 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261020 | Symmetrix™ L Spinal System | 2026 | 0 |
| K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System | 2025 | 0 |
| K251080 | IdentiTi II Cervical Interbody System | 2025 | 0 |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | 2025 | 0 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 40 years and passes through 18 companies; a new generation was cleared every 8 months on median.
- 151 of the 1,404 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K261020 (Medtronic Sofamor Danek USA, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 30 other devices also cite its predicate K203714.
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. 2024, 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 IdentiTi™ II Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by…
Read the full statement (228 words)
The IdentiTi™ II Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the IdentiTi II System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The IdentiTi II Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation, the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
AMP™ II Anti-Migration Plate may be used with IdentiTi II LIF interbody spacers to provide integrated fixation. IdentiTi II LIF spacers with >20° lordosis must be used with AMP II Anti-Migration Plate in addition to supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242364 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242364: IdentiTi™ II Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242364
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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