# K080281: Pathway

- Pathway: 510(k) (Traditional)
- Applicant: Custom Spine, Inc.
- Decided: May 1, 2008 after 87 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: 5 generations back to K841189 (1984). 9 ancestors in all.
188 later devices descend from it; 3 cite it directly.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 1.
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.
- K001340: Stackable Cage System, Depuyacromed (2000) Summary page 1.
- K030833: Depuy Acromed VBR System, Depuyacromed (2003) Summary page 1.

## Most influential descendants
- K151310: Amendia Interbody Fusion Devices (2016), 169 descendants of its own
- K160924: Amendia Interbody Fusion Devices (2016), 166 descendants of its own
- K171496: Tritanium C Anterior Cervical Cage (2017), 129 descendants of its own
- K180364: HD LifeSciences Cervical IBFD System (2018), 106 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 descendants of its own

## Indications for use
The PATHWAY Interbody Fusion Device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S 1) 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 Interbody Fusion 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 Device. The PATHWAY 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, multiple devices are implanted in the appropriate locations to provide support to the spine for a posterior surgery.

Source page: https://510kreport.com/device/K080281
Methodology: https://510kreport.com/methodology