# K152501: Spinal Jaxx Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Neuropro Spinaljaxx, Inc.
- Decided: Jun 29, 2016 after 302 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K003155 (2001). 102 ancestors in all.
No later device cites it as a predicate yet.
1 of 103 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 4.
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 4.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 4.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 4.
- K072970: Patriot Spacers, Globus Medical, Inc. (2008) Summary page 4.
- K140280: Forticore, Nanovis, LLC (2014) Summary page 4.

## Recalls of this device
- Jan 18, 2018 · Class II · Z-1350-2018: The implant size is incorrectly etched on the implant. The size listed on the box is correct.

## Indications for use
The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2 – S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.

Source page: https://510kreport.com/device/K152501
Methodology: https://510kreport.com/methodology