# K251444: Endoskeleton™ Interbody Systems

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Sep 4, 2025 after 118 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: 26 generations back to K841189 (1984). 470 ancestors in all.
No later device cites it as a predicate yet.
1 of 471 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Medtronic Sofamor Danek USA, Inc. (2021) Summary page 7.

## Indications for use
Endoskeleton™ TA Interbody System The Endoskeleton™ TA Interbody System devices including those with macro-, micro- and nano-roughened surface textured features are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD, defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The Endoskeleton™ TA Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The device is to be used with supplemental fixation cleared by the FDA for use in the lumbar spine. These patients may also have up to Grade | spondylolisthesis or retrolisthesis at the involved level(s). Endoskeleton™ TA Interbody System is indicated to be used with autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. Endoskeleton™ TA VBR Interbody System The Endoskeleton™ TA Vertebral Body Replacement Interbody System devices including those with macro-, micro- and nano-roughened surface textured features are for use in the thoracolumbar spine (T1 — L5) in skeletally mature patients replacing all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The Endoskeleton™ TA Vertebral Body Replacement Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Endoskeleton™ TA Vertebral Body Replacement Interbody System is intended for use with supplemental internal spinal fixation systems cleared by the FDA for use in the lumbar spine. The Endoskeleton™ TA Vertebral Body Replacement Interbody System may be used with autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. Endoskeleton™ TAS & TAS Hyperlordotic Interbody System The Endoskeleton™ TAS Interbody System devices including those with macro-, micro- and nano-roughened surface textured features are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD, defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade | spondylolisthesis or retrolisthesis at the involved levels. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is a standalone system intended to be used with the bone screws provided and requires no additional supplementary fixation. The Endoskeleton™ TAS Interbody 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 Endoskeleton™ TAS Interbody 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 device is indicated to be used with autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. Indications for Hyperlordotic Devices 216" The Endoskeleton™ TAS Hyperlordotic Interbody System (216°) devices including those with macro-, micro- and nano-roughened surface textured features are indicated for use in skeletally mature patients with DDD, degenerative spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade | spondylolisthesis or retrolisthesis at the involved levels. Implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is indicated to be used with autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. The Endoskeleton™ TAS Hyperlordotic Interbody System must be used with a posterior supplemental internal spinal fixation cleared by the FDA for use in the lumbar spine. Endoskeleton™ TC Interbody System The Endoskeleton™ TC Interbody System devices including those with macro-, micro- and nano-roughened surface textured features are indicated for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. The Endoskeleton™ TC Interbody System is indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. Endoskeleton™ TCS Interbody System The Endoskeleton™ TCS Interbody System devices including those with macro-, micro- and nano-roughened surface textured features are intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or instability, as confirmed by imaging studies(radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. The device is indicated to be used with autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. The device is a stand-alone system when used with Endoskeleton™ TCS Interbody System integrated screws. When used without the integrated screws, the Endoskeleton™ TCS Interbody System requires additional supplemental fixation cleared by the FDA for the cervical spine. Endoskeleton™ TL Interbody System The Endoskeleton™ TL Interbody System devices including those with macro-, micro- and nano-roughened surface textured features are indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD, defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation cleared by the FDA for use in the lumbar spine. These patients may also have up to Grade | spondylolisthesis or retrolisthesis at the involved levels. The Endoskeleton™ TL Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. It is indicated to be used with autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. Endoskeleton™ TL Hyperlordotic Interbody System The Endoskeleton™ TL Hyperlordotic Interbody System (=16°) devices with macro-, micro- and nano-roughened surface textured features are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD, defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade | spondylolisthesis or retrolisthesis at the involved levels. Patients should have received 6 months of non-operative treatment prior to treatment with the Endoskeleton™ TL Hyperlordotic Interbody System. Patients with previous non-fusion spinal surgery at the involved levels may be treated with the device. The Endoskeleton™ TL Hyperlordotic Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Interbody Device is indicated to be used with autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. The Endoskeleton™ TL Hyperlordotic Interbody System must be used with an integrated lateral plate and bone screw and additionally must be used with posterior supplemental internal spinal fixation cleared by the FDA for use in the lumbar spine. Endoskeleton™ TO Interbody System The Endoskeleton™ TO Interbody System devices including those with macro-, micro- and nano-roughened surface textured features are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD, defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation cleared by the FDA for use in the lumbar spine. These patients may also have up to Grade | spondylolisthesis or retrolisthesis at the involved levels. The Endoskeleton™ TO Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The device is indicated to be used with autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. Endoskeleton™ TT Interbody System The Endoskeleton™ TT Interbody System devices including those with macro-, micro- and nano-roughened surface textured features are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD, defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis at one or two contiguous levels from L2-S1 whose condition requires the use of interbody fusion. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation cleared by the FDA for use in the lumbar spine. These patients may also have up to Grade | spondylolisthesis or retrolisthesis at the involved levels. The Endoskeleton™ TT Interbody System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. It is indicated to be used with autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

Source page: https://510kreport.com/device/K251444
Methodology: https://510kreport.com/methodology