# K203014: EndoLIF Delta-Cage and DoubleWedge-Cage

- Pathway: 510(k) (Traditional)
- Applicant: Joimax GmbH
- Decided: Sep 1, 2021 after 335 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: 1 generation back to K151143 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151143: EndoLIF On-Cage, Joimax GmbH (2015) Summary page 4.

## Indications for use
The EndoLIF® Delta-Cage and DoubleWedge-Cage are intended 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. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). EndoLIF® Delta-Cage and DoubleWedge-Cage are to be used with autogeneous bone and implanted via a posterior or posteriolateral approach. The EndoLIF® Delta-Cage and DoubleWedge-Cage are to be used with supplemental FDA cleared fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an EndoLIF® cage.

Source page: https://510kreport.com/device/K203014
Methodology: https://510kreport.com/methodology