510(k) · Cleared
ClearedIdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 7, 2022 as substantially equivalent to K203201 (Nu Vasive, Incorporated, 2021) and 7 other predicates after an 88-day review. Its family tree reaches back 30 generations to 1984. 2 of the 1,196 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it.
- Decided
- Oct 7, 2022
- Review
- 88 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 30 generations to K841189 (1984). 1,167 ancestors in all, the oldest K761228 (1976). 28 later devices descend from it, 9 citing it directly. 2 of the 1,196 devices in this family, counting this one, have a Class I recall.
- Root · 30 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 26 generations between
- 3 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 2 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 1 generation backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- This deviceK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- Descendant · cites it directly · 7 of its ownK240368 E3D™-A Interbody SystemEvolution Spine · 2024
- Descendant · cites it directly · 7 of its ownK232097 IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. · 2023 · Recalled
- Descendant · cites it directly · 7 of its ownK231438 Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. · 2023
- Descendant · cites it directly · 7 of its ownK223611 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023
- Descendant · 2 generations on · 6 of its ownK241846 E3D™-C Interbody SystemEvolution Spine · 2024
Show all 30 generations
- Root · 30 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 29 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 28 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 27 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 26 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 25 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 24 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 23 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 22 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 21 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 20 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 19 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 18 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 17 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 16 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 15 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 14 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 13 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 12 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 11 generations backK160955 Tritanium® PL CageStryker · 2016
- 10 generations backK162262 Tritanium® PL CageStryker · 2016
- 9 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 8 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 7 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 6 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 5 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 4 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 3 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 2 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 1 generation backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- This deviceK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 28 · See all- K240368E3D™-A Interbody SystemEvolution Spine · 2024 · cites it directly7descendants
- K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. · 2023 · cites it directly7descendants
- K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. · 2023 · cites it directly7descendants
- K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023 · cites it directly7descendants
- K241846E3D™-C Interbody SystemEvolution Spine · 2024 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −30 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −29 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −28 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −27 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −26 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −25 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −24 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −23 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −22 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −21 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −20 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −19 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −18 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −17 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −16 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −15 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −14 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −13 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −12 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −11 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −10 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −9 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −8 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −7 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −6 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −5 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −4 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −3 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −2 | 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 | — |
| 0 (this device) | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| +1 | K240368 | E3D™-A Interbody System | Evolution Spine | 2024 | — |
| +1 | K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | 2023 | 1 |
| +1 | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. | 2023 | — |
| +1 | K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023 | — |
| +2 | K241846 | E3D™-C Interbody System | Evolution Spine | 2024 | — |
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 | 1 | 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 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 21 | 0 |
| 1996 | 23 | 0 |
| 1997 | 21 | 0 |
| 1998 | 34 | 0 |
| 1999 | 24 | 0 |
| 2000 | 35 | 0 |
| 2001 | 45 | 0 |
| 2002 | 42 | 0 |
| 2003 | 51 | 0 |
| 2004 | 67 | 0 |
| 2005 | 57 | 0 |
| 2006 | 42 | 0 |
| 2007 | 41 | 0 |
| 2008 | 83 | 1 |
| 2009 | 62 | 0 |
| 2010 | 55 | 1 |
| 2011 | 70 | 0 |
| 2012 | 46 | 0 |
| 2013 | 50 | 0 |
| 2014 | 49 | 0 |
| 2015 | 43 | 0 |
| 2016 | 37 | 0 |
| 2017 | 32 | 0 |
| 2018 | 18 | 0 |
| 2019 | 12 | 0 |
| 2020 | 13 | 0 |
| 2021 | 6 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 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? (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 |
|---|---|---|---|
| * | K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Summary page 9…oduct Code Trade Name Manufacturer Primary Predicate Device NuVasive Thoracolumbar K203201 MAX, PHM, OVD NuVasive Interbody Systems… | 2021 |
| * | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Summary page 9…e Interbody Systems Additional Predicate Devices MAX, OVD, PHM, IdentiTi™ and Transcend™ K220782 Alphatec Spine OVE Interbody Syst… | 2022 |
| * | K183705 | IdentiTi Porous Ti Interbody SystemSummary page 10…510(k) Product Code Trade Name Manufacturer MAX, PHM, OVD, IdentiTi™ Porous Ti Interbody K183705 Alphatec Spine ODP Syst… | 2019 |
| * | K180480 | ATEC Universal Spacer SystemSummary page 10…rous Ti Interbody K183705 Alphatec Spine ODP System K180480 MAX, PHM ATEC Universal Spacer System Alphatec Spine MAX, OVD, PHM, Iden… | 2018 |
| * | K182746 | ATEC ALIF and LLIF Spacer SystemSummary page 10…Alphatec Spine OVE Interbody System ATEC ALIF and LLIF Spacer K182746 MAX, PHM, OVD Alphatec Spine Syst… | 2018 |
| * | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Summary page 10…Alphatec Spine System MAX, ODP, OVD, IdentiTi and Transcend Interbody K211805 Alphatec Spine PHM Syst… | 2021 |
| * | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface TechnologySummary page 10…Alphatec Spine PHM Systems Anteralign™ Spinal System with K214010 MAX, OVD, OLO Titan nanoLOCK™ Surface Medtronic Techno… | 2022 |
| * | K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…Summary page 10…logy SeaSpine MAX, ODP, OVD, SeaSpine Spacer System K210497 Orthopedics OVE, MQP NanoM… | 2021 |
What descends from it? (28)
See all 289 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240368 | E3D™-A Interbody System | 2024 | 7 |
| K232097 | IdentiTi ALIF Interbody Systems | 2023 | 7 |
| K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | 2023 | 7 |
| K223611 | Calibrate LTX Interbody System | 2023 | 7 |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | 2024 | 5 |
| K242364 | IdentiTi™ II Interbody System | 2024 | 4 |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi… | 2025 | 3 |
| K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | 2024 | 1 |
| K232504 | Calibrate CCX Interbody System | 2023 | 1 |
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 38 years and passes through 17 companies; a new generation was cleared every 8 months on median.
- 123 of the 1,167 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K240368 (Evolution Spine, 2024) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K203201.
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?
The IdentiTi Porous Ti 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…
Read the full statement (1,339 words)
The IdentiTi Porous Ti 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 Porous Ti System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The IdentiTi Porous Ti Interbody System is intended for use on patients who have had at least six months of non-operative 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 and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
AMP™ Anti-Migration Plate may be used with IdentiTi LIF interbody spacers to provide integrated fixation. IdentiTi LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation. IdentiTi ALIF interbody spacers with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.
The IdentiTi Interbody System with advanced NanoTec surface treatment 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 NanoTec Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The IdentiTi NanoTec Interbody System is intended for use on patients who have had at least six months of non-operative 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 and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
AMP™ Anti-Migration Plate may be used with IdentiTi NanoTec LIF interbody spacers to provide integrated fixation. IdentiTi NanoTec LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.
The IdentiTi ALIF Standalone Interbody System is indicated for spinal fusion procedures from L2 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis and/or spinal stenosis 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. These patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.
Additionally, the IdentiTi ALIF Standalone Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis (>Grade 1) and spinal stenosis at one or two adjacent levels, the IdentiTi ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The IdentiTi ALIF Standalone Interbody System is intended for use on patients who have had at least six months of non-operative 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.
The IdentiTi ALIF Standalone Interbody System implants of <20° are a standalone system. The IdentiTi ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
The IdentiTi ALIF Standalone Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from L2 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis and/or spinal stenosis 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. These patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.
Additionally, the IdentiTi NanoTec ALIF Standalone Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis (>Grade 1) and spinal stenosis at one or two adjacent levels, the IdentiTi Nanotec ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The IdentiTi NanoTec ALIF Standalone Interbody System is intended for use on patients who have had at least six months of non-operative 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.
The IdentiTi NanoTec ALIF Standalone Interbody System implants of <20° are a standalone system. The IdentiTi NanoTec ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
The Transcend PEEK 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 Transcend PEEK Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Transcend PEEK Interbody System is intended for use on patients who have had at least six months of non-operative 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 and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
AMP™ Anti-Migration Plate may be used with Transcend LIF interbody spacers to provide integrated fixation. Transcend LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation. Transcend ALIF interbody spacers with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.
The Transcend PEEK Interbody System with advanced NanoTec surface treatment 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 Transcend NanoTec Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Transcend NanoTec Interbody System is intended for use on patients who have had at least six months of non-operative 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 and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
AMP™ Anti-Migration Plate may be used with Transcend NanoTec LIF interbody spacers to provide integrated fixation. Transcend NanoTec LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental 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/K222028 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone 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/K222028
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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