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Augment Off-Axis Instrument System

by Fix Surgical 2 variants

510(k) K241043

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 ongoing

This device is named in the recall

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 · Special NumberK241043 Date15 May 2024ClearedStatusActive

Recalls

5 recalls · 5 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-2531-2026 FDA Class II initiated 20 May 2026
    • Ongoing Z-2528-2026 FDA Class II initiated 20 May 2026
    • Ongoing Z-2530-2026 FDA Class II initiated 20 May 2026
    • Ongoing Z-2529-2026 FDA Class II initiated 20 May 2026
    • Ongoing Z-2527-2026 FDA Class II initiated 20 May 2026

    Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

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  • Withdrawn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
PHX
Device Class
Class II
Regulation
21 CFR Part 888.3660
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 Augment Off-Axis Instrument System is a reusable surgical instrument set designed for glenoid bone and tissue preparation in shoulder arthroplasty procedures. It is classified under the FDA’s product code PHX as a shoulder joint metal/polymer semi-constrained cemented prosthesis accessory, intended for use in both reverse and anatomic total shoulder arthroplasty. The system facilitates precise off-axis preparation of the glenoid cavity, ensuring optimal alignment and fit for subsequent implant placement. Its specialized design supports enhanced surgical control and accuracy during glenoid reaming and shaping.

This instrument system is intended for single-use per surgical procedure, though the manufacturer’s specifications indicate it is reusable under proper sterilization protocols. It is not MRI-safe and must be handled in accordance with standard surgical instrument sterilization and storage guidelines. The system is cleared under FDA 510(k) clearance (K241043) as a Class II orthopedic device, adhering to regulatory requirements for shoulder joint procedures. No additional sterility or regulatory certifications beyond the stated FDA clearance are provided in the available data.

Other devices from Fix Surgical

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 Augment Off-Axis Instrument System used for?

    The Augment Off-Axis Instrument System is designed specifically for glenoid bone and tissue preparation during shoulder arthroplasty procedures. It enables precise off-axis reaming and shaping of the glenoid cavity, ensuring optimal alignment and fit for subsequent implant placement in both reverse and anatomic total shoulder arthroplasty. This specialized design helps surgeons achieve greater accuracy and control during the critical glenoid preparation step.

  • Is the Augment Off-Axis Instrument System intended for single-use or reusable?

    While the manufacturer’s specifications indicate the system is reusable under proper sterilization protocols, it is intended for single-use per surgical procedure. Reuse requires adherence to standard surgical instrument sterilization and storage guidelines to maintain safety and efficacy. Always follow the manufacturer’s instructions for sterilization to ensure device integrity.

  • How should the Augment Off-Axis Instrument System be stored?

    The system must be stored in accordance with standard surgical instrument protocols to preserve its functionality and sterility. Since it is not MRI-safe, it should be kept away from MRI environments to prevent potential damage or interference. Proper packaging and storage conditions are essential to maintain its performance for future use.

  • What regulatory clearance does the Augment Off-Axis Instrument System hold?

    The Augment Off-Axis Instrument System is cleared under FDA 510(k) clearance (K241043) as a Class II orthopedic device. This clearance is specific to its use as an accessory for shoulder joint metal/polymer semi-constrained cemented prosthesis procedures, ensuring it meets regulatory requirements for safety and effectiveness in shoulder arthroplasty.

  • Does the system include any special features for surgical precision?

    Yes, the system is engineered with specialized tools that facilitate off-axis preparation of the glenoid cavity. This design allows surgeons to achieve precise alignment and shaping, which is critical for the successful placement of implants in both reverse and anatomic shoulder arthroplasty. The enhanced control provided by these instruments helps reduce procedural variability and improves surgical outcomes.