# K134038: Camber Spine Diagon Oblique Cage

- Pathway: 510(k) (Special)
- Applicant: Camber Spine
- Decided: Mar 20, 2014 after 79 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: 12 generations back to K841189 (1984). 52 ancestors in all.
28 later devices descend from it; 1 cites it directly.
0 of 81 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 1.

## Most influential descendants
- K172064: Ti-Diagon Oblique TLIF (2017), 27 descendants of its own
- 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

## Indications for use
The Camber Spine Technologies Diagon Oblique Cage 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 Diagon Oblique Cage is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach. Camber Spine Technologies Diagon Oblique Cage 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/K134038
Methodology: https://510kreport.com/methodology