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Synthes Oracle Spacer

by Synthes Spine Co.Lp 510(k)

Active United States

510(k) K062933

Overview

The Synthes Oracle Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. It is designed to be used with Synthes supplemental internal fixation systems such as ATLP, VentroFix and USS.

The device is supplied as a radiolucent vertebral body replacement that provides anterior decompression of the spinal cord and neural tissues when used in partial and total vertebrectomy procedures. It is authorized under FDA 510(k) clearance with product code MQP and is intended for single use in the treatment of tumor or trauma-related vertebral body conditions.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062933 Date31 Jan 2007ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MQP
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Synthes Oracle Spacer used for?

    The Synthes Oracle Spacer is intended to replace a collapsed, damaged, or unstable vertebral body in the thoracolumbar spine (T1-L5) resulting from tumor or trauma. It provides anterior decompression of the spinal cord and neural tissues during partial or total vertebrectomy procedures when used with Synthes supplemental internal fixation systems such as ATLP, VentroFix, or USS.

  • Is the Synthes Oracle Spacer sterile and for single use only?

    Yes, the Synthes Oracle Spacer is supplied sterile and is intended for single use only. This is explicitly stated in the device description, which confirms it is designed for one-time implantation in the treatment of tumor or trauma-related vertebral body conditions to ensure patient safety and prevent cross-contamination.

  • What fixation systems is the Synthes Oracle Spacer compatible with?

    The Synthes Oracle Spacer is designed to be used with Synthes supplemental internal fixation systems, specifically ATLP, VentroFix, and USS. These systems provide additional stability after vertebral body replacement, and the spacer’s design ensures compatibility with these constructs for optimal spinal reconstruction in thoracolumbar procedures.