# K253377: Expandable Titanium PLIF/TLIF System

- Pathway: 510(k) (Special)
- Applicant: Spectrum Spine, Inc.
- Decided: Oct 24, 2025 after 24 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: 28 generations back to K841189 (1984). 607 ancestors in all.
No later device cites it as a predicate yet.
1 of 608 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201024: Expandable Titanium PLIF/TLIF System, Spectrum Spine, LLC (2021) Summary page 6.
- K240838: Spectrum Spine Cervical Cage System, Spectrum Spine, Inc. (2024) Summary page 6.
- K243074: Spectrum Spine Lumbar Cage System, Spectrum Spine, Inc. (2025) Summary page 6.
- K193256: Anjon Bremer Halo System, Anjon Holdings, LLC (2020) Summary page 6.

## Indications for use
The Spectrum Spine Expandable Titanium PLIF/TLIF System includes interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-Sl). 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). Spectrum Spine Expandable Titanium PLIF/TLIF System 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/K253377
Methodology: https://510kreport.com/methodology