# K172064: Ti-Diagon Oblique TLIF

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: Sep 15, 2017 after 70 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: 13 generations back to K003155 (2001). 91 ancestors in all.
27 later devices descend from it; 5 cite it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121254: Camber Spine Technologies TLS 5.0 Inerbody Cage, Camber Spine Technologies (2013) Summary page 4.
- K134038: Camber Spine Diagon Oblique Cage, Camber Spine (2014) Summary page 4.
- K133967: Interbody Cage System, Aurora Spine (2014) Summary page 4.

## Most influential descendants
- K212904: SeaSpine WaveForm C Interbody System (2021), 15 descendants of its own
- K213420: WaveForm L System, WaveForm TO System, WaveForm TA System (2022), 11 descendants of its own
- K222732: WaveForm A Interbody System (2022), 9 descendants of its own
- K233694: Meridian Interbody System; WaveForm A Interbody System (2024), 8 descendants of its own
- K233414: Shoreline ACS Interbody System; Shoreline RT Interbody System (2023), 8 descendants of its own

## Indications for use
The Camber Spine Technologies Ti-Diagon® Oblique TLIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Camber Spine Technologies Ti-Diagon® Oblique TLIF is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach. Camber Spine Technologies Ti-Diagon® Oblique TLIF implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K172064
Methodology: https://510kreport.com/methodology