# K252240: Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Spine
- Decided: Mar 30, 2026 after 256 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: 28 generations back to K841189 (1984). 659 ancestors in all.
No later device cites it as a predicate yet.
1 of 660 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240838: Spectrum Spine Cervical Cage System, Spectrum Spine, Inc. (2024) Summary page 5.
- K243074: Spectrum Spine Lumbar Cage System, Spectrum Spine, Inc. (2025) Summary page 5.
- K222988: neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical, Ht Medical D.B.A. Xenix Medical (2023) Summary page 5.

## Indications for use
Spectrum Spine Cervical Cage System The Spectrum Spine Cervical Cage 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. These patients should have had at least six weeks of nonoperative treatment. The Spectrum Spine Cervical Cage 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 cortico-cancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. Spectrum Spine Lumbar Cage System The Spectrum Spine Lumbar Cage System devices with roughened surface textured features, are indicated for use in skeletally mature patients with lumbar degenerative disc disease (ODD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion, confirmed by imaging studies (radiographs, CT, MRI). DOD is defined as discogenic pain with degeneration of the disc. DOD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had at least six months of nonoperative treatment. The Spectrum Spine Lumbar Cage System is indicated to be used with supplemental fixation cleared by the FDA for use in the lumbar spine and 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/K252240
Methodology: https://510kreport.com/methodology