# K240838: Spectrum Spine Cervical Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Spine, Inc.
- Decided: May 30, 2024 after 64 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: 26 generations back to K841189 (1984). 588 ancestors in all.
4 later devices descend from it; 4 cite it directly.
1 of 593 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 4.
- K100889: Endoskeleton TC, Titan Spine, LLC (2010) Summary page 5.
- K212853: Cervical Stand-Alone System, Eminent Spine, LLC (2021) Summary page 5.

## Most influential descendants
- K243074: Spectrum Spine Lumbar Cage System (2025), 2 descendants of its own
- K252240: Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (2026), 0 descendants of its own
- K254105: Hive™ Standalone Cervical System and Hive™ C Interbody System (2026), 0 descendants of its own
- K253377: Expandable Titanium PLIF/TLIF System (2025), 0 descendants of its own

## Indications for use
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 corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

Source page: https://510kreport.com/device/K240838
Methodology: https://510kreport.com/methodology