# K143479: Bluefin Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Tides Medical
- Decided: Sep 25, 2015 after 291 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: 16 generations back to K841189 (1984). 163 ancestors in all.
2 later devices descend 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)
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 4.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 4.
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 4.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 4.
- K151472: NuVasive CoRoent Lumbar System, Nu Vasive, Incorporated (2015). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K193255: Largo PEEK Interbody System (2020), 1 descendant of its own
- K223231: Ti-Largo Cervical Interbody System (2023), 0 descendants of its own

## Indications for use
The Bluefin™ Interbody Cages — Lumbar are indicated for use with autograft 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). Bluefin™ 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. The Bluefin™ 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. Bluefin™ 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. Bluefin™ 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.

Source page: https://510kreport.com/device/K143479
Methodology: https://510kreport.com/methodology