# K201024: Expandable Titanium PLIF/TLIF System

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Spine, LLC
- Decided: Apr 29, 2021 after 374 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: 20 generations back to K841189 (1984). 159 ancestors in all.
5 later devices descend from it; 3 cite it directly.
1 of 165 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172696: FORZA® XP Expandable Spacer System, Orthofix, Inc. (2018) Summary page 5.
- K080537: L-Varlock, Kiscomedica S.A. (2008) Summary page 5.
- K173518: Spectrum Spine Expandable Cages (SSEC), Spectrum Spine, LLC (2019) Summary page 5.
- K140411: Altera Spacer, Globus Medical, Inc. (2014) Summary page 5.

## Most influential descendants
- 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
- K221172: FOCUS Interbody System (2022), 0 descendants of its own

## Indications for use
The Spectrum Spine Expandable PLIF/TLIF Interbody Cage System is an interbody fusion device intended for use in patients with degenerative disc disease (DOD) at one or two contiguous levels of the lumbosacral spine (L2-S1 ). DOD 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). Expandable PLIF/TLIF implants are to be filled with autogenous bone graft material. The device are intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K201024
Methodology: https://510kreport.com/methodology