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, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone 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 Jun 9, 2022 as substantially equivalent to K211805 (Alphatec Spine, Inc., 2021) and 5 other predicates after an 84-day review. Its family tree reaches back 29 generations to 1984. 2 of the 958 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it.
- Decided
- Jun 9, 2022
- Review
- 84 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 29 generations to K841189 (1984). 921 ancestors in all, the oldest K761228 (1976). 36 later devices descend from it, 5 citing it directly. 2 of the 958 devices in this family, counting this one, have a Class I recall.
- Root · 29 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations between
- 3 generations backK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- 2 generations backK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- 1 generation backK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- This deviceK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
- Descendant · cites it directly · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- Descendant · cites it directly · 13 of its ownK222973 IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous…Alphatec Spine, Inc. · 2022
- Descendant · cites it directly · 8 of its ownK232432 E3D™-A Interbody SystemEvolution Spine · 2024
- 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
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 backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 11 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 10 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 9 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 8 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 7 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 6 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 5 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 4 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 3 generations backK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- 2 generations backK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- 1 generation backK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- This deviceK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 36 · See all- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · cites it directly28descendants
- K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc. · 2022 · cites it directly13descendants
- K232432E3D™-A Interbody SystemEvolution Spine · 2024 · cites it directly8descendants
- K240368E3D™-A Interbody SystemEvolution Spine · 2024 · 2 generations on7descendants
- K232097IdentiTi ALIF Interbody SystemsAlphatec 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 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −11 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −10 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −9 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −8 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −7 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −6 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −5 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −4 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −3 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| −2 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| −1 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| 0 (this device) | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
| +1 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| +1 | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti… | Alphatec Spine, Inc. | 2022 | — |
| +1 | K232432 | E3D™-A Interbody System | Evolution Spine | 2024 | — |
| +2 | K240368 | E3D™-A Interbody System | Evolution Spine | 2024 | — |
| +2 | K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | 2023 | 1 |
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 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 9 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 14 | 0 |
| 1996 | 22 | 0 |
| 1997 | 16 | 0 |
| 1998 | 30 | 0 |
| 1999 | 21 | 0 |
| 2000 | 30 | 0 |
| 2001 | 42 | 0 |
| 2002 | 37 | 0 |
| 2003 | 48 | 0 |
| 2004 | 63 | 0 |
| 2005 | 49 | 0 |
| 2006 | 36 | 0 |
| 2007 | 38 | 0 |
| 2008 | 77 | 1 |
| 2009 | 53 | 0 |
| 2010 | 47 | 1 |
| 2011 | 50 | 0 |
| 2012 | 28 | 0 |
| 2013 | 29 | 0 |
| 2014 | 36 | 0 |
| 2015 | 28 | 0 |
| 2016 | 15 | 0 |
| 2017 | 16 | 0 |
| 2018 | 9 | 0 |
| 2019 | 4 | 0 |
| 2020 | 9 | 0 |
| 2021 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 10 | 0 |
| 2025 | 11 | 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? (6)
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 |
|---|---|---|---|
| * | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Summary page 11…e Trade Name Manufacturer Primary Predicate Device PHM, MAX, OVD, IdentiTi™ Porous Ti Interbody K211805 Alphatec Spine ODP System, ==… | 2021 |
| * | K183705 | IdentiTi Porous Ti Interbody SystemSummary page 12…Interbody System Additional Predicate Devices MAX, PHM, OVD, IdentiTi™ Porous Ti Interbody K183705 Alphatec Spine ODP Syste… | 2019 |
| * | K180480 | ATEC Universal Spacer SystemSummary page 12…orous Ti Interbody K183705 Alphatec Spine ODP System K180480 MAX, PHM ATEC Universal Spacer System Alphatec Spine Ident… | 2018 |
| * | K202812 | IdentiTi Cervical Standalone Interbody SystemSummary page 12…K180480 MAX, PHM ATEC Universal Spacer System Alphatec Spine IdentiTi™ Cervical Standalone K202812 OVE Alphatec Spine Inter… | 2020 |
| * | K203742 | IdentiTi ALIF Standalone Interbody SystemSummary page 12…Alphatec Spine Interbody System IdentiTi™ ALIF Standalone K203742 OVD Alphatec Spine Inter… | 2021 |
| * | K202889 | Able Medical Devices Valkyrie Thoracic Fixation SystemSummary page 12…andalone K203742 OVD Alphatec Spine Interbody System K202889 HRS, HWC Valkyrie Thoracic Fixation JM Longyear System… | 2021 |
What descends from it? (36)
See all 365 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™… | 2022 | 28 |
| K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System… | 2022 | 13 |
| K232432 | E3D™-A Interbody System | 2024 | 8 |
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | 2024 | 3 |
| K223513 | UniVy™ OsteoVy™-Ti Cervical IBF 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 13 companies; a new generation was cleared every 8 months on median.
- 96 of the 921 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K222028 (Alphatec Spine, 2022) has gone furthest, with 28 descendants of its own.
- 5 other devices also cite its predicate K211805.
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 in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine. Thoracic: Tl-T2 to Tll-T12, or at the thoracolumbar junction (Tl2-Ll ), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). Lumbar: Ll-L2 to L5-Sl, for…
Read the full statement (1,229 words)
The IdentiTi Porous Ti Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: Tl-T2 to Tll-T12, or at the thoracolumbar junction (Tl2-Ll ), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
Lumbar: Ll-L2 to L5-Sl, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confmned by history and radiographic studies.
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 for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
The IdentiTi Interbody System with advanced NanoTec smface treatment is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: Tl-T2 to Tll-T12, or at the thoracolumbar junction (Tl2-Ll ), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
Lumbar: Ll-L2 to L5-Sl, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confmned by history and radiographic studies.
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 for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
The Transcend PEEK Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: Tl-T2 to Tll-Tl2, or at the thoracolumbar junction (Tl2-Ll ), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
Lumbar: Ll-L2 to L5-Sl, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confmned by history and radiographic studies.
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 for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
The Transcend PEEK Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: Tl-T2 to Tll-Tl2, or at the thoracolumbar junction (Tl2-Ll ), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
Lumbar: Ll-L2 to L5-Sl, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confmned by history and radiographic studies.
The Transcend NanoTec PEEK Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
The IdentiTi ALIF Standalone Interbody System is indicated for spinal fusion procedures in skeletally mature patients. The IdentiTi AUF Standalone lnterbody System implants of ≤20° are a standalone system. The IdentiTi AUF 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 AUF Standalone lnterbody System is intended for use at one or two contiguous levels in the lumbar spine (L2-Sl) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defmed as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The IdentiTi AUF Standalone lnterbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
The IdentiTi ALIF Standalone Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures in skeletally mature patients. 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 supplements! 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 at one or two contiguous levels in the lumbar spine (L2-S 1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confmned by history and radiographic studies. 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 for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft
The IdentiTi Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-Tl) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confmned by history and radiographic studies). These patients should have received at least six weeks of non-operative treatment prior to treatment with the device. The IdentiTi Cervical Standalone Interbody System is to be used with autograft and/or allograft composed of cancellous and/or cortico-cancellous bone graft and implanted via an open, anterior approach. The IdentiTi Cervical Standalone Interbody System is intended to be used with the bone screw fiXation provided and requires no additional fiXation.
The IdentiTi Cervical Standalone Interbody System with advanced NanoTec surface treatment is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-Tl) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of non-operative treatment prior to treatment with the device. The IdentiTi NanoTec Cervical Standalone lnterbody System is to be used with autograft and/or allograft composed of cancellous and/or cortico-cancellous bone graft and implanted via an open, anterior approach. The IdentiTi NanoTec Cervical Standalone Interbody System is intended tu be used with the bone screw fixation provided and requires no additional fiXation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220782 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220782: 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, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220782
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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