# K123969: Xiphos

- Pathway: 510(k) (Traditional)
- Applicant: Difusion Technologies
- Decided: Feb 7, 2013 after 43 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: 8 generations back to K841189 (1984). 37 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100042: Difusion Technologies Xiphos Interbody Fusion System, Difusion Technologies (2010) Summary page 2.
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 2.
- K080822: VU Apod Intervertabral Body Fusion Device, Theken Spine, LLC (2008) Summary page 2.

## Most influential descendants
- K133340: Spineworks Anterior Lumbar Device (2014), 13 descendants of its own
- 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

## Indications for use
When used as an intervertebral body fusion device, the DiFUSION Technologies XIPHOS Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. When used as a vertebral body replacement device, the DiFUSION Technologies XIPHOS System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The XIPHOS System is intended for use in the thoracolumbar spine (from Ti to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomnechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The DiFUSION Technologies XIPHOS System is intended to be used with autograft or allograft bone.

Source page: https://510kreport.com/device/K123969
Methodology: https://510kreport.com/methodology