# K243074: Spectrum Spine Lumbar Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Spine, Inc.
- Decided: Apr 4, 2025 after 189 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: 27 generations back to K841189 (1984). 606 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 609 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 5.
- K230219: Eminent Spine 3D Lumbar Interbody Fusion Systems, Eminent Spine, LLC (2023) Summary page 6.
- K240838: Spectrum Spine Cervical Cage System, Spectrum Spine, Inc. (2024) Summary page 6.
- K193256: Anjon Bremer Halo System, Anjon Holdings, LLC (2020) Summary page 6.
- K131612: Anyplus; Alif Peek Cages, Plif Peek Cages, T-Plif Peek Cages, Tlif Peek Cages, GS Medical Co., Ltd. (2014) Summary page 6.
- K201024: Expandable Titanium PLIF/TLIF System, Spectrum Spine, LLC (2021) Summary page 6.
- K173518: Spectrum Spine Expandable Cages (SSEC), Spectrum Spine, LLC (2019) Summary page 6.

## Most influential descendants
- K252240: Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage 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 Lumbar Cage System devices with roughened surface textured features, are indicated for use in skeletally mature patients with lumbar degenerative disc disease (DOD) 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/K243074
Methodology: https://510kreport.com/methodology