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INFINITY OCT System

by Medtronic Sofamor Danek USA, Inc. 3 variants

510(k) K163375

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 ongoing

Recall on shared 510(k) K163375; other models may be affected

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK163375 Date21 Aug 2017ClearedStatusActive

Recalls

5 recalls · 5 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-1409-2023 FDA Class II initiated 16 Feb 2023 on shared 510(k) K163375
    • Ongoing Z-1413-2023 FDA Class II initiated 16 Feb 2023 on shared 510(k) K163375
    • Ongoing Z-1412-2023 FDA Class II initiated 16 Feb 2023 on shared 510(k) K163375
    • Ongoing Z-1411-2023 FDA Class II initiated 16 Feb 2023 on shared 510(k) K163375
    • Ongoing Z-1410-2023 FDA Class II initiated 16 Feb 2023 on shared 510(k) K163375

    Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
NKG
Device class
Class II
Regulation
21 CFR Part 888.3075
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Infinity OCT System is an orthopedic device classified as a Posterior Cervical Screw System, designed to provide immobilization and stabilization of spinal segments in the craniocervical junction, cervical spine (C1–C7), and upper thoracic spine (T1–T3). It is intended for use as an adjunct to spinal fusion in cases of acute or chronic instability, including traumatic fractures or dislocations. The system employs screws and connectors to secure vertebral alignment, facilitating surgical correction and long-term stabilization.

The device is supplied as a reusable surgical implant and is regulated under FDA 510(k) clearance (K163375) as a Class II orthopedic product. It is intended for use in sterile surgical environments and requires proper handling, sterilization, and storage as per manufacturer guidelines. The system’s design adheres to orthopedic standards for spinal fixation, ensuring compatibility with standard surgical techniques and imaging protocols. No additional regulatory approvals beyond the 510(k) clearance are stated.

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Questions

AI-generated answers, 1 Oct 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 INFINITY OCT System used for in spinal surgery?

    The INFINITY OCT System is designed to provide immobilization and stabilization of spinal segments in the craniocervical junction, cervical spine (C1–C7), and upper thoracic spine (T1–T3). It is intended as an adjunct to spinal fusion for cases involving acute or chronic instability, such as traumatic fractures or dislocations, helping to secure vertebral alignment during surgical correction and ensuring long-term stabilization.

  • Is the INFINITY OCT System reusable or single-use?

    The INFINITY OCT System is supplied as a reusable surgical implant. It is intended for use in sterile surgical environments and must be handled, sterilized, and stored according to the manufacturer’s guidelines to maintain its integrity and performance for repeated procedures.

  • What regulatory clearance does the INFINITY OCT System hold?

    The INFINITY OCT System holds FDA 510(k) clearance (K163375) as a Class II orthopedic device. This clearance confirms its substantial equivalence to a predicate device and ensures it meets regulatory standards for spinal fixation applications in the specified regions of the spine.

  • How should the INFINITY OCT System be stored?

    The INFINITY OCT System must be stored in a clean, dry environment to prevent contamination. Since it is reusable, it requires proper sterilization between uses as per manufacturer instructions. Storage should follow guidelines to preserve the device’s sterility and functionality for surgical procedures.

  • Does the system require special surgical techniques or imaging protocols?

    The INFINITY OCT System is designed to be compatible with standard surgical techniques and imaging protocols commonly used in spinal fixation procedures. Its design adheres to orthopedic standards, ensuring it integrates seamlessly with existing workflows for accurate placement and assessment during surgery.