# K090566: Pathway Avid

- Pathway: 510(k) (Traditional)
- Applicant: Custom Spine, Inc.
- Decided: Jun 1, 2009 after 90 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). 15 ancestors in all.
639 later devices descend from it; 7 cite it directly.
1 of 655 devices in its family (counting itself) has 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.
- K070082: XY Cor Spinal Implant for Minimal Invasive Spinal Surgery, Vertebration,Inc (2007) Summary page 1.

## Most influential descendants
- K112359: Prow Fusion (2011), 601 descendants of its own
- K130820: Expandable Lumbar Interbody System (2013), 593 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K150994: NuVasive CoRoent Thoracolumbar Implants (2015), 402 descendants of its own

## Indications for use
The PATHWAY Intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-Sl) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved level(s). The device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rods systems and anterior screw and rod systems). The device is intended to be used with an autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device. The PATHWAY AVID Intervertebral body fusion device must be inserted using a transforaminal approach.

Source page: https://510kreport.com/device/K090566
Methodology: https://510kreport.com/methodology