# K201793: EDEN Peek Cage

- Pathway: 510(k) (Traditional)
- Applicant: Jmt Co., Ltd.
- Decided: Sep 13, 2021 after 440 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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 K003155 (2001). 120 ancestors in all.
No later device cites it as a predicate yet.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181380: LnK Lumbar Interbody Fusion Cage System, L&K BIOMED Co., Ltd. (2018) Summary page 4.
- K171749: Velofix (tm) Interbody Fusion System, U&I Corporation (2017) Summary page 4.

## Indications for use
The EDEN Peek Cage - PLIF Type is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involvedlevel(s).This device is to be used with autogenous bone graft. The EDEN Peek Cage System is 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. The EDEN Peek Cage - ACIF Type is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K201793
Methodology: https://510kreport.com/methodology