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Anax 5.5 Spinal System

by U&I Corporation 510(k)

Active United States

510(k) K173524

Overview

The Anax 5.5 Spinal System is a posterior spinal fixation device designed for minimally invasive surgery (MIS). It consists of pedicle screws, rods, set screws, connectors, and transverse linking mechanisms, enabling surgeons to construct rigid spinal implant constructs. This system is intended for stabilizing the spine and promoting spinal fusion in noncervical regions. The pedicle screws feature a self-tapping function to facilitate precise placement.

Used in clinical settings by orthopedic surgeons, the Anax 5.5 Spinal System is supplied as a reusable or single-use kit, depending on component specifications. The device is classified under product code NKB and holds an FDA 510(k) clearance (K173524) as substantially equivalent to a predicate device. No specific sterility or MRI safety information is provided in the data, though standard surgical precautions apply. Components are sized for adult spinal applications and must be stored per manufacturer instructions.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK173524 Date13 Dec 2017ClearedStatusActive

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-2672-2020 FDA Class II initiated 26 May 2020

    6.0x50mm poly-reduction screws were laser etched 6.0x45

Specification

510(k)

510(k) Number
FDA Product Code
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Anax 5.5 Spinal System used for?

    The Anax 5.5 Spinal System is designed for posterior spinal fixation in minimally invasive surgery (MIS). It provides rigid stabilization and promotes spinal fusion in noncervical regions by combining pedicle screws, rods, set screws, connectors, and transverse linking mechanisms. The self-tapping screws simplify precise screw placement, making it suitable for complex spinal reconstructions.

  • How is the Anax 5.5 Spinal System supplied?

    The system is available as either a reusable or single-use kit, depending on the specific components included. This flexibility allows surgeons to choose based on clinical workflow and infection control protocols. Always follow the manufacturer’s storage and handling instructions to ensure proper use.

  • Are the components of the Anax 5.5 Spinal System sterile?

    The provided data does not specify sterility details for the Anax 5.5 Spinal System. Standard surgical precautions should be followed, including adhering to manufacturer guidelines for preparation and use. If sterility is critical for your procedure, confirm with U&I Corporation.

  • What sizes are available for the Anax 5.5 Spinal System?

    The components of the Anax 5.5 Spinal System are designed for adult spinal applications. While exact screw and rod sizes are not detailed in the provided data, the system is engineered to accommodate standard adult anatomical dimensions. For precise sizing options, refer to the manufacturer’s technical documentation.

  • How should the Anax 5.5 Spinal System be stored?

    Storage instructions for the Anax 5.5 Spinal System must be followed as directed by U&I Corporation. Proper storage ensures component integrity and functionality. If the system is supplied as a kit, components should be stored separately if not intended for immediate use, and any single-use items should be handled according to sterile technique guidelines.