# K211805: IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Sep 22, 2021 after 103 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K841189 (1984). 467 ancestors in all.
38 later devices descend from it; 6 cite it directly.
1 of 506 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183705: IdentiTi Porous Ti Interbody System, Alphatec Spine, Inc. (2019) Summary page 8.
- K202587: ATEC Lateral Interbody System, Alphatec Spine, Inc. (2020) Summary page 8.
- K201614: TxTiHA IBF System, AxTiHA Stand-Alone ALIF System, Innovasis, Inc. (2020) Summary page 8.
- K181435: ATEC Cervical Spacer System, Alphatec Spine, Inc. (2018) Summary page 8.
- K203201: NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System, Nu Vasive, Incorporated (2021) Summary page 8.

## Most influential descendants
- 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 (2022), 36 descendants of its own
- 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 (2022), 28 descendants of its own
- K222973: IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem (2022), 13 descendants of its own
- K232432: E3D™-A Interbody System (2024), 8 descendants of its own
- K222455: Calibrate LTX Interbody System (2022), 8 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K211805
Methodology: https://510kreport.com/methodology