# K143143: Pathway Elif

- Pathway: 510(k) (Traditional)
- Applicant: Custom Spine, Inc.
- Decided: Jul 22, 2015 after 261 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: 7 generations back to K841189 (1984). 11 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111774: Pathway Model 07XXXX, Custom Spine (2011) Summary page 4.

## Most influential descendants
- K153123: Genesys Spine Apache Interbody Fusion System (2016), 12 descendants of its own
- K161438: Genesys Spine Apache® Anterior Lumbar Interbody Fusion System (2016), 11 descendants of its own
- K182987: Genesys Spine 3DP Lumbar Interbody System (2019), 9 descendants of its own
- K191489: Genesys Spine 3DP Cervical Interbody System (2020), 7 descendants of its own
- K211417: F3D-C2 Cervical Stand-Alone System (2022), 3 descendants of its own

## Indications for use
The PATHWAY ELIF device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The PATHWAY ELIF device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, anterior plate systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft. Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY ELIF device(s). The PATHWAY ELIF device can be used in one of two methods: Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF, a single device is implanted in the appropriate location to provide support for a transforaminal approached surgery. Posterior Lumbar Interbody Fusion (PLIF) Used as a PLIF, two devices are implanted in the appropriate locations to provide support to the spine for a posterior surgery.

Source page: https://510kreport.com/device/K143143
Methodology: https://510kreport.com/methodology