510(k) · Cleared
ClearedIdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec 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 Sep 22, 2021 as substantially equivalent to K183705 (Alphatec Spine, Inc., 2019) and 4 other predicates after a 103-day review. Its family tree reaches back 27 generations to 1984. 1 of the 506 devices in its family, counting itself, has a Class I recall. 38 later devices descend from it.
- Decided
- Sep 22, 2021
- Review
- 103 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 27 generations to K841189 (1984). 467 ancestors in all, the oldest K792352 (1979). 38 later devices descend from it, 6 citing it directly. 1 of the 506 devices in this family, counting this one, has a Class I recall.
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations between
- 3 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 2 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 1 generation backK202587 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2020
- This deviceK211805 IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody…Alphatec Spine, Inc. · 2021
- Descendant · cites it directly · 36 of its ownK220782 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 · 2 generations on · 8 of its ownK232432 E3D™-A Interbody SystemEvolution Spine · 2024
- Descendant · cites it directly · 8 of its ownK222455 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022
Show all 27 generations
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 26 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 25 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 24 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 23 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 21 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 20 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 19 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 17 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 16 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 15 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 14 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 13 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 12 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 11 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 10 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 9 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 8 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 7 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 6 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 5 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 4 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 3 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 2 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 1 generation backK202587 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2020
- This deviceK211805 IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody…Alphatec Spine, Inc. · 2021
Showing 5 of 38 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 38 · See all- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · cites it directly36descendants
- 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 · 2 generations on8descendants
- K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −26 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −25 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −24 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −23 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −21 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −20 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −19 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −17 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −16 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −15 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −14 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −13 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −12 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −11 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −10 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −9 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −8 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −7 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −6 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −5 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −4 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −3 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −2 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −1 | K202587 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2020 | — |
| 0 (this device) | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi… | Alphatec Spine, Inc. | 2021 | — |
| +1 | 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 | — |
| +2 | K232432 | E3D™-A Interbody System | Evolution Spine | 2024 | — |
| +1 | K222455 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 15 | 0 |
| 2002 | 13 | 0 |
| 2003 | 19 | 0 |
| 2004 | 30 | 0 |
| 2005 | 22 | 0 |
| 2006 | 16 | 0 |
| 2007 | 18 | 0 |
| 2008 | 52 | 1 |
| 2009 | 35 | 0 |
| 2010 | 26 | 0 |
| 2011 | 29 | 0 |
| 2012 | 18 | 0 |
| 2013 | 22 | 0 |
| 2014 | 25 | 0 |
| 2015 | 17 | 0 |
| 2016 | 7 | 0 |
| 2017 | 12 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 4 | 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.
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? (5)
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 |
|---|---|---|---|
| * | K183705 | IdentiTi Porous Ti Interbody SystemSummary page 8…e Trade Name Manufacturer Primary Predicate Device IdentiTi Porous Ti Interbody K183705 PHM, MAX, OVD Alphatec Spine System… | 2019 |
| * | K202587 | ATEC Lateral Interbody SystemSummary page 8…PHM, MAX, OVD Alphatec Spine System Additional Predicate Devices K202587 MAX, OVD, PHM ATEC Lateral Interbody System Alphatec Spine TxTiHA™ IBF… | 2020 |
| * | K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemSummary page 8…Devices K202587 MAX, OVD, PHM ATEC Lateral Interbody System Alphatec Spine TxTiHA™ IBF System, K201614 MAX, OVD AxTiHA™ Stand-Alone ALIF Innovasis, Inc. System… | 2020 |
| * | K181435 | ATEC Cervical Spacer SystemSummary page 8…TxTiHA™ IBF System, K201614 MAX, OVD AxTiHA™ Stand-Alone ALIF Innovasis, Inc. System K181435 ODP ATEC Cervical Spacer System Alphatec Spine K203201 MAX, PHM, OVD CoRoent Tho… | 2018 |
| * | K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Summary page 8…Innovasis, Inc. System K181435 ODP ATEC Cervical Spacer System Alphatec Spine K203201 MAX, PHM, OVD CoRoent Thoracolumbar System NuVasive, Inc. K211… | 2021 |
What descends from it? (38)
See all 386 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™… | 2022 | 36 |
| 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 |
| K222455 | Calibrate LTX Interbody System | 2022 | 8 |
| K260038 | E3D™-C Interbody System | 2026 | 1 |
| K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | 2024 | 1 |
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 13 companies; a new generation was cleared every 9 months on median.
- 53 of the 467 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K220782 (Alphatec Spine, Inc., 2022) has gone furthest, with 36 descendants of its own.
- 15 other devices also cite its predicate K183705.
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?
Transcend NanoTec Cervical Platform The Transcend PEEK Cervical lnterbody System with advanced NanoTec surface treatment is intended for spinal fusion procedures at one or two levels from C2-Tl in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Transcend PEEK Cervical NanoTec Interbody…
Read the full statement (1,168 words)
Transcend NanoTec Cervical Platform
The Transcend PEEK Cervical lnterbody System with advanced NanoTec surface treatment is intended for spinal fusion procedures at one or two levels from C2-Tl in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Transcend PEEK Cervical NanoTec Interbody System is intended for use with supplemental fixation systems and with autograft or allograft (e.g., allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients should have had six weeks of non-operative treatment.
Transcend NanoTec Thoracolumbar Platform
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 (ODD) 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.
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.
IdentiTi Cervical Platform
The IdentiTi Cervical Porous Ti Interbody System is intended for spinal fusion procedures at one or two levels from C2-Tl in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defmed as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The IdentiTi Cervical Porous Ti Interbody System is intended for use with supplemental fixation systems and with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of non-operative treatment.
IdentiTi Thoracolumbar Platform
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.
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.
Transcend Cervical Platform
The Transcend PEEK Cervical lnterbody System is intended for spinal fusion procedures at one or two levels from C2-Tl in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Transcend PEEK Cervical lnterbody System is intended for use with supplemental fiXation systems and with autugraft or allograft (e.g., allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients should have had six weeks of non-operative treatment.
Transcend Thoracolumbar Platform
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 Tl1-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 (ODD) 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.
AMP Anti-Migration Plate may be used with Transcend-LIF interbody spacers to provide integrated fixation. Transcend-LIP spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fiXation.
IdentiTi NanoTec Cervical Platform
The IdentiTi Cervical lnterbody System with advanced NanoTec surface treatment is intended for spinal fusion procedures at one or two levels from C2-Tl in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The IdentiTi Cervical NanoTec lnterbody System is intended for use with supplemental fiXation systems and with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of non-operative treatment.
IdentiTi NanoTec Thoracolumbar Platform
The IdentiTi 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 Til-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 (ODD) 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.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211805: IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211805
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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