# K183407: Triton Cage

- Pathway: 510(k) (Traditional)
- Applicant: Medyssey USA, Inc.
- Decided: Aug 30, 2019 after 263 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: 18 generations back to K841189 (1984). 123 ancestors in all.
No later device cites it as a predicate yet.
1 of 124 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152475: FORZA PTC Spacer System, Orthofix, Inc. (2016) Summary page 4.
- K140348: Interbody Cage, Eisertech, LLC (2015) Summary page 4.

## Indications for use
The Triton Cage is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the treated level may be treated. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation instrumentation that has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K183407
Methodology: https://510kreport.com/methodology