Davantis/Antelys Vertebral Body Replacements
510(k) K053292
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053292 | Date19 Jan 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MQP
- FDA applicant
- Scient'X USA, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
Davantis/Antelys Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T4-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices and must be used with ISOBAR Ø6.2 hemispherical screws with offset clamps and Ø5.5 rods to enhance stability. The implant is oval shaped with an interior containing three compartments to provide space for bone graft and is always implanted in the vertical position. The superior and inferior surfaces have ridges to interface with the vertebral endplates to resist migration.
These components are available in various heights. The device is supplied non-sterile and is intended for single use. It received FDA 510(k) clearance (K053292) as substantially equivalent to a predicate device under product code MQP, with special clearance type and review by the Orthopedic advisory committee. Manufacturer information includes Scien'Tx USA, Inc. located at 1001 Oakwood Blvd., Round Rock, TX 78681.