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Forza Spacer System

by Orthofix, Inc.

510(k) K103111

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103111 Date23 Mar 2011ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1037-2012 FDA Not yet classified initiated 6 Feb 2012

    The 8mm and 10mm Rotating Cutters may fracture during use, specifically during disc space preparation. If an 8mm or 10mm Rotating Cutter does Fracture during use, it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Forza Spacer System is a titanium alloy expandable interbody device used for Posterior Lumbar Interbody Fusion (PLIF) and Transforaminal Lumbar Interbody Fusion (TLIF) procedures. After insertion into the disc space, the interbodies can be expanded to fit the patient anatomy.

The system is supplied as a single-use device and requires specific storage conditions. It has received FDA 510(k) clearance with the product code MAX and is intended for use in orthopedic procedures.

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Forza Spacer System used for?

    The Forza Spacer System is a titanium alloy expandable interbody device designed for Posterior Lumbar Interbody Fusion (PLIF) and Transforaminal Lumbar Interbody Fusion (TLIF) procedures. It can be expanded after insertion to fit the patient's specific anatomy.

  • Is the Forza Spacer System reusable or single-use?

    The Forza Spacer System is supplied as a single-use device and requires specific storage conditions. It should not be reused on multiple patients as this could compromise sterility and device integrity.

  • What regulatory approvals does the Forza Spacer System have?

    The Forza Spacer System has received FDA 510(k) clearance with the product code MAX. It is classified under the orthopedic advisory committee and is intended for use in orthopedic procedures.

  • What materials is the Forza Spacer System made from?

    The Forza Spacer System is constructed from titanium alloy, which provides strength and biocompatibility for spinal fusion procedures. The material choice supports the device's expandable design while maintaining structural integrity.