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Synthes Xrl

by Synthes Spine Co.Lp 510(k)

Active United States

510(k) K103320

Overview

The Synthes XRL is an expandable vertebral body replacement device classified under the nomenclature for orthopedic spinal implants. It is designed to replace collapsed, damaged, or unstable vertebral bodies in the thoracolumbar spine (T1-L5) due to trauma or tumor-related fractures, providing structural support without requiring fusion.

This device is supplied as a radiolucent, modular system intended for single-use in spinal surgery. It is cleared for use in the United States under FDA 510(k) clearance (K103320) as a Class 2 Orthopedic device (product code MQP). The expandable design allows for internal packing with bone graft materials, ensuring prolonged stability in the absence of fusion.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103320 Date20 Oct 2011ClearedStatusActive

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

1 recall · FDA

    • Terminated Z-1681-2014 FDA Class II initiated 8 Apr 2014

    Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.

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 types of spinal conditions is the Synthes XRL designed to address specifically within the thoracolumbar region?

    The Synthes XRL is designed to replace collapsed, damaged, or unstable vertebral bodies in the thoracolumbar spine (T1-L5) caused by trauma or tumor-related fractures. It provides structural support without requiring spinal fusion, making it suitable for cases where immediate stabilization is needed.

  • Is the Synthes XRL system reusable or intended for single-use, and what does this mean for surgical workflow?

    The Synthes XRL is explicitly supplied as a single-use device, meaning it is intended for one surgical procedure only. This design choice reduces the risk of cross-contamination and simplifies inventory management, as clinicians do not need to clean or reprocess the device between cases.

  • How does the expandable design of the Synthes XRL benefit patients who require vertebral body replacement?

    The expandable design of the Synthes XRL allows for internal packing with bone graft materials, which enhances stability over time—even without fusion. This modular approach helps accommodate varying vertebral body sizes and ensures a secure fit while promoting integration with surrounding bone.

  • What regulatory pathway was followed for FDA clearance of the Synthes XRL, and what does this mean for its clinical use?

    The Synthes XRL received FDA clearance through a Traditional 510(k) process (K103320) under the Orthopedic advisory committee (OR), with a decision dated October 20, 2011. This means the device was determined to be substantially equivalent to a legally marketed predicate, confirming its safety and effectiveness for its intended use as described in the clearance.