# K092904: Pathway Ivb/VBR

- Pathway: 510(k) (Traditional)
- Applicant: Custom Spine, Inc.
- Decided: Dec 22, 2009 after 92 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: 7 generations back to K841189 (1984). 25 ancestors in all.
296 later devices descend from it; 3 cite it directly.
0 of 322 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043479: MC+ Partial VBR, Ldr Spine USA (2005) Summary page 1.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.
- K083637: Calix Spinal Implant System, X-Spine Systems, Inc. (2009) Summary page 1.

## Most influential descendants
- K101812: Construx Mini Peek Spacer System (2010), 291 descendants of its own
- K121649: Construx Mini Peek TI Spacer System (2012), 289 descendants of its own
- K132999: Cervical Stand Alone System (2014), 281 descendants of its own
- K142152: Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System (2015), 280 descendants of its own
- K150788: Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices (2015), 202 descendants of its own

## Indications for use
When used as an intervertebral body fusion device, the Custom Spine PATHWAY ACIF is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should receive 6 weeks of non-operative treatment prior to treatment with the Custom Spine ACIF. When used as a vertebral body replacement, the Custom Spine PATHWAY ACIF is intended for use in the thoracic and/or throcolumbar spine (TI-L-5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e. partial or total vertebrectomy procedures) due to tumor or trauma (i.e. fracture). The PATHWAY ACIF, when used as a vertebral body replacement, can be packed with autograft. For all indications, the device is intended to be used with supptemental fixation systems that have been cleared for use in cervical, thoracic, or lumbar spine (posterior pedicle screw systems, anterior plate systems, and anterior screw and rod systems).

Source page: https://510kreport.com/device/K092904
Methodology: https://510kreport.com/methodology