# K100042: Difusion Technologies Xiphos Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Difusion Technologies
- Decided: Oct 1, 2010 after 266 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: 7 generations back to K841189 (1984). 27 ancestors in all.
864 later devices descend from it; 6 cite it directly.
1 of 892 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 1.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 1.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K043479: MC+ Partial VBR, Ldr Spine USA (2005) Summary page 1.

## Most influential descendants
- K111512: Bonebac T-Plif Intervertebral Body Fusion Device System (2011), 762 descendants of its own
- K120368: Capstone Control Spinal System (2012), 761 descendants of its own
- K121760: Capstone Spinal System (2012), 723 descendants of its own
- K123027: Capstone (R) Spinal System (2013), 709 descendants of its own
- K131082: Interform Interbody Cage System (2013), 595 descendants of its own

## Indications for use
Intervertebral Body Fusion Device: The DiFUSION Technologies XIPHOS Interbody Fusion System is indicated for intervertelbral 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. DOID 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. Vertebral Body Replacement Device: The DiFUSION Technologies XIPHOS System of implants 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 biornechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.

Source page: https://510kreport.com/device/K100042
Methodology: https://510kreport.com/methodology