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Isola Spinal Systems

by Depuyacromed 510(k)

Active United States

510(k) K012971

Overview

The Isola Spinal System is a pedicle screw system classified as an orthopedic spinal fixation device. It is designed to provide immobilization and stabilization of spinal segments in skeletally mature patients, serving as an adjunct to spinal fusion for treating instabilities or deformities in the thoracic, lumbar, and sacral regions.

This system is intended for surgical use by orthopedic specialists in hospital operating rooms. It is supplied as a reusable surgical instrument set and is not sterile at time of shipment; sterilization is performed prior to use. The device is regulated under FDA 510(k) clearance (K012971) and is intended for specific spinal pathologies as outlined in its approved indications. No MRI safety information or single-use designation is provided in the available data.

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

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK012971 Date5 Oct 2001ClearedStatusActive

Coverage

1 jurisdiction

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  • 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  • Withdrawn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
MNH
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What regions of the spine is the Isola Spinal System designed to stabilize, and how is it used in surgery?

    The Isola Spinal System is designed to stabilize and immobilize spinal segments in the thoracic, lumbar, and sacral regions. It is used as an adjunct to spinal fusion surgery to treat instabilities or deformities in skeletally mature patients. The system is intended for surgical use by orthopedic specialists in hospital operating rooms, providing fixation to support spinal alignment during recovery.

  • Is the Isola Spinal System reusable or single-use, and how should it be prepared for surgery?

    The Isola Spinal System is supplied as a reusable surgical instrument set and is not sterile at the time of shipment. Sterilization must be performed prior to use in the operating room, ensuring proper cleaning and sterilization protocols are followed to maintain safety and efficacy.

  • What type of regulatory clearance does the Isola Spinal System have, and how was it determined?

    The Isola Spinal System holds FDA 510(k) clearance under the reference number K012971. The clearance was determined through a review process by the Orthopedic (OR) Advisory Committee, where the device was classified as substantially equivalent to a legally marketed predicate device, specifically under a special clearance type.

  • Are there specific sizes or models available for the Isola Spinal System, and if so, how would a clinician determine the appropriate fit?

    While the provided data does not explicitly list individual sizes or models, the Isola Spinal System is designed for use in the thoracic, lumbar, and sacral regions, suggesting a range of screw lengths and diameters to accommodate different anatomical needs. Clinicians would typically rely on preoperative imaging and surgical planning to determine the appropriate screw sizes and placement for optimal fixation and stabilization.