# K253260: ORIO-3D Cage System

- Pathway: 510(k) (Traditional)
- Applicant: SpineCraft
- Decided: Apr 16, 2026 after 199 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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). 478 ancestors in all.
No later device cites it as a predicate yet.
1 of 479 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212701: Eminent Spine 3D Cervical Interbody Fusion System, Eminent Spine (2023) Summary page 6.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 6.
- K191243: HEDRON Cervical Spacers, Globus Medical, Inc. (2019) Summary page 6.
- K203342: CONSTRUX Mini Ti Spacer System, Orthofix, Inc. (2021) Summary page 6.
- K230219: Eminent Spine 3D Lumbar Interbody Fusion Systems, Eminent Spine, LLC (2023) Summary page 6.
- K191391: HEDRON Lumbar Spacers, Globus Medical, Inc. (2019) Summary page 6.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 6.
- K221936: Standalone ALIF Interbody Fusion System, Eminent Spine (2022) Summary page 6.
- K230894: NuVasive Modulus ALIF System, Nu Vasive, Incorporated (2023) Summary page 6.

## Indications for use
The ORIO-3D Intervertebral Body Fusion Cervical Cages are indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine in skeletally mature patients with cervical degenerative disc disease (DDD) and/or cervical spinal instability, as confirmed by imaging studies, that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-Tl. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and imaging studies. The ORIO-3D Cervical Cages are designed for use with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone and with an FDA cleared cervical supplemental fixation system. The hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the ORIO-3D Cervical Cages in the cervical spine. The ORIO-3D Intervertebral Body Fusion Transforaminal Lumbar (TLIF or P-TLIF) Cages are indicated for intervertebral Body fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-Sl). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and imaging studies. Additionally, the ORIO-3D Intervertebral Body Fusion Transforaminal Lumbar Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis and sagittal deformity. The ORIO-3D Transforaminal Lumbar Cages are designed for use with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or cortico-cancellous bone. The ORIO-3D Transforaminal Lumbar Cages are intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbosacral spine. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the ORIO-3D Transforaminal Lumbar Cages. The ORIO-3D Intervertebral Body Fusion Anterior Lumbar (ALIF) Cages are indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Additionally, the ORIO-3D Intervertebral Body Fusion Anterior Lumbar Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis and sagittal deformity. When used with three titanium alloy ANTERIS bone screws, the ORIO-3D ALIF 10 ° - 20 ° lordotic cages may be used as a standalone cage system in patients with DDD. Hyperlordotic ORIO-3D ALIF cages (>20 ° lordosis) must be used with supplemental internal spinal fixation systems that are cleared for use in the lumbosacral spine. The ORIO-3D ALIF Cages are designed for use with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or cortico-cancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

Source page: https://510kreport.com/device/K253260
Methodology: https://510kreport.com/methodology