Xiphos
510(k) K123969
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123969 | Date7 Feb 2013 | StatusActive |
Official records
- FDA 510(k) database K123969
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Xiphos is an interbody fusion device made from VESTAKEEP PEEK material, indicated for intervertebral body fusion of the lumbar spine from L2 to S1 in skeletally mature patients who have had six months of non-operative treatment. It is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease.
The device is supplied as a single-use implant and is manufactured by Difusion Technologies. It has received FDA 510(k) clearance with the product code MAX and is designed for structural requirements in spinal implant applications. The device is not specified as MRI safe and should be stored according to the manufacturer's instructions.
Similar devices
Other devices filed under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).
- PATHWAY by Custom Spine, Inc.
- CAPSTONE® Spinal System 2990922 by MEDTRONIC SOFAMOR DANEK, INC.
- Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic by Pioneer Surgical Technology Inc.
- Perimeter Interbody Fusion Device by MEDTRONIC SOFAMOR DANEK, INC.
- MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF by MIRUS LLC
- Lucent Ti-Bond Systems by SPINAL ELEMENTS, INC.
- nva, nvp, and nvt by NVISION BIOMEDICAL TECHNOLOGIES, INC
- SCARLET® AL-T Intervertebral body fusion device SCA-LL 30 20-S by Spineart
- CONCORDE 187827212 by MEDOS INTERNATIONAL SARL
- Lumbar IBF System by SPINEFRONTIER, INC.