# K193255: Largo PEEK Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Flospine, LLC
- Decided: Feb 20, 2020 after 86 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: 17 generations back to K841189 (1984). 164 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143479: Bluefin Interbody System, Tides Medical (2015) Summary page 4.

## Most influential descendants
- K223231: Ti-Largo Cervical Interbody System (2023), 0 descendants of its own

## Indications for use
Largo™ Interbody Cages - Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Largo™ Interbody Cages - Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Largo™ Interbody Cages - Cervical are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. Largo™ Interbody Cages - Lumbar are indicated for use with autograft bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Largo™ Interbody Cages - Lumbar are intended to be used with supplemental spinal fixation systems, such as pedicle screws. Patients should be skeletally mature and have six (6) months of non-operative therapy prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K193255
Methodology: https://510kreport.com/methodology