# 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

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Jan 12, 2021 after 75 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: 24 generations back to K841189 (1984). 293 ancestors in all.
94 later devices descend from it; 6 cite it directly.
1 of 388 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201820: NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic 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, 3DP Interfixated ALIF System, Nu Vasive, Incorporated (2020) Summary page 13.
- K153419: NuVasive CoRoent Thoracolumbar System, Nu Vasive, Incorporated (2016) Summary page 14.
- K161230: NuVasive Lumbar Interbody Implants, Nu Vasive, Incorporated (2016) Summary page 14.
- K170962: NuVasive® CoRoent® Thoracolumbar System, Nu Vasive, Incorporated (2017) Summary page 14.
- K181386: NuVasive Brigade Lateral System, Nu Vasive, Incorporated (2018) Summary page 14.
- K170592: NuVasive BASE Interfixated Titanium System, Nu Vasive, Incorporated (2017) Summary page 14.
- K173153: Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System, Nu Vasive, Incorporated (2017) Summary page 14.
- K181860: NuVasive Cohere Thoracolumbar Interbody System, Nu Vasive, Incorporated (2018) Summary page 14.
- K193541: NuVasive Cohere Thoracolumbar Interbody System, Nu Vasive, Incorporated (2020) Summary page 14.
- K172341: NuVasive® Modulus TLIF Interbody System, Nu Vasive, Incorporated (2017) Summary page 14.
- K192760: NuVasive Modulus XLIF Interbody System, Nu Vasive, Incorporated (2019) Summary page 14.
- K193593: NuVasive 3DP Interfixated ALIF System, Nu Vasive, Incorporated (2020) Summary page 14.
- K200953: NuVasive® Cohere® Thoracolumbar Interbody System, Nu Vasive, Incorporated (2020) Summary page 14.

## Most influential descendants
- K211258: Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System (2021), 75 descendants of its own
- K212524: Anteralign Spinal System with Titan nanoLOCK Surface Technology (2021), 55 descendants of its own
- K214010: Anteralign Spinal System with Titan nanoLOCK Surface Technology (2022), 49 descendants of its own
- K211805: IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System (2021), 38 descendants of its own
- 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

## Indications for use
The NuVasive CoRoent Thoracolumbar System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The NuVasive CoRoent Thoracolumbar System (XL platform) implants are intended for use in interbody fusions in the thoracic spine, from Tl to T12, and at the thoracolumbar junction (T12-Ll), and the CoRoent Thoracolumbar System (XL and L platforms) implants are intended for use in the lumbar spine, from L 1 to S 1, for the treatment of symptomatic disc degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of disco genie origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive CoRoent Thoracolumbar System (XL and L platforms) can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The NuVasive CoRoent XL Interfixated System implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The devices are to be used in patients who have had at least six months of non-operative treatment. The NuVasive CoRoent XL Interfixated System implants are intended for use in interbody fusions in the lumbar spine, from L2 to LS, following discectomy in 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. The NuVasive CoRoent XL Interfixated System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Brigade System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Standalone System (lordotic angles of 8° and 12°) is a standalone system. The Brigade Hyperlordotic System (lordotic angles of 15° to 30°) must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment. The Brigade System is intended for use in interbody fusions in the lumbar spine from L2 to Sl, following discectomy in the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defmed as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade System platform implants can also 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 and spinal stenosis at one or two adjacent levels, the Brigade System platform must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The Brigade Lateral System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Lateral System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment. The Brigade Lateral System is intended for use in interbody fusions in the lumbar spine from L2 to SI, following discectomy in the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenos is 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. The Brigade Lateral System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The BASE Interfixated Titanium System is indicated for spinal fusion procedures in skeletally mature patients. The BASE Interfixated Titanium System 10° - 20° lordotic cages may be used as a standalone system. The BASE Interfixated Titanium System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment. The BASE Interfixated Titanium System is intended for use in interbody fusions in the lumbar spine from L2 to SI, following discectomy in 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. The BASE Interfixated System implants can also 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 and spinal stenosis at one or two adjacent levels, the BASE Interfixated Titanium System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The NuVasive Coalesce Thoracolumbar Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The NuVasive Coalesce Thoracolumbar Interbody Fusion System is intended for use in interbody fusions in the thoracic spine from Tl to Tl2 and at the thoracolumbar junction (Tl2-Ll), and is intended for use in the lumbar spine, from Ll to Sl, for the treatment of symptomatic disc degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of disco genie origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Coalesce Thoracolumbar Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The NuVasive Cohere Thoracolumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. When used with or without the Cohere XLIF internal fixation, the system is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The NuVasive Cohere Thoracolumbar Interbody System is intended for use in interbody fusions in the thoracic spine, from Tl to Tl2, and at the thoracolumbar junction (Tl2-Ll), and in the lumbar spine, from LI to Sl, for the treatment of symptomatic disc degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Cohere Thoracolumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The NuVasive Modulus XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. When used with or without Modulus XLIF internal fixation, the system is intended for use with supplemental spinal fixation system cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The NuVasive Modulus XLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from Tl to T12 and at the thoracolumbar junction (T12-Ll), and for use in the lumbar spine from LI to Sl, for the treatment of symptomatic disc degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Modulus XLIF Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The NuVasive Modulus TLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The NuVasive Modulus TLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from Tl to T12 and at the thoracolumbar junction (T12-Ll), and for use in the lumbar spine from LI to Sl, for the treatment of symptomatic disc degeneration (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Modulus TLIF Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The NuVasive Modulus ALIF System is indicated for spinal fusion procedures in skeletally mature patients. The Modulus ALIF System 10°-20° lordotic cages may be used as a standalone system. The Modulus ALIF System 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment. The NuVasive Modulus ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to Sl, following discectomy in 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. The Modulus ALIF System implants can also 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 and spinal stenosis at one or two adjacent levels, the Modulus ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

Source page: https://510kreport.com/device/K203201
Methodology: https://510kreport.com/methodology