# K173518: Spectrum Spine Expandable Cages (SSEC)

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Spine, LLC
- Decided: Mar 7, 2019 after 478 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: 14 generations back to K841189 (1984). 66 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090507: Modification to LDR Spine Roi Interbody Fusion System; Roi-a Implant System, Ldr Spine USA (2009) Summary page 5.
- K112095: Acculif TL-Peek Ibf Cage, Coalign Innovations, Inc. (2011) Summary page 5.
- K123281: Acculif TL-Peek Cage, Coalign Innovations, Inc. (2013) Summary page 5.
- K123752: Acculif TL and PL Cage, Coalign Innovations, Inc. (2013) Summary page 5.
- K123231: Caliber Spacers, Globus Medical, Inc. (2013) Summary page 5.

## Most influential descendants
- K201024: Expandable Titanium PLIF/TLIF System (2021), 5 descendants of its own
- K243074: Spectrum Spine Lumbar Cage System (2025), 2 descendants of its own
- K212075: ShurFit Lumbar Interbody System (2021), 1 descendant of its own
- 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 Expandable Cages (SSEC) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). SSEC implants are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K173518
Methodology: https://510kreport.com/methodology