ARBOR External Fixation System

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

ARBOR External Fixation

Generic Name

Surgical instrument handle, non-torque-limiting

Device Name

Non-Invasive Instruments

Model / Reference

630.407

Primary DI / UDI-DI

00849044026030

Basic UDI-DI

0193982NONINVINSTLT

Direct Marketing DI

00849044026030

510(k) Number

K172438 ↗

FDA Product Code

KTT 510(k)

LXH GUDID

EMDN Code

L091199 Orthopaedic prosthetics instruments, reusable - other

GMDN Term

Surgical instrument handle, non-torque-limiting

Device Class

Class I EUDAMEDGUDID

Class II 510(k)

Regulation

21 CFR Part 888.3030 510(k)

888.4540 GUDID

EU market of registration

Netherlands

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

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See all devices from Globus Medical, Inc. →

• What types of bone injuries or conditions is the Arbor External Fixation System specifically designed to address?

  The Arbor External Fixation System is designed to stabilize long bone fractures or correct deformities by applying controlled external forces. It is particularly useful in orthopedic settings for trauma cases, such as complex fractures, or reconstructive procedures where precise alignment and gradual correction of bone alignment are required without invasive surgery.

• Is the Arbor External Fixation System reusable or intended for single-use, and how does this affect its sterility?

  The Arbor External Fixation System is supplied as a sterile, single-use device. This design ensures patient safety by preventing cross-contamination and reduces the risk of infection, which is critical in orthopedic procedures where sterility is paramount.

• What configurations or sizes are available for the Arbor External Fixation System, and how does this accommodate different patient needs?

  The Arbor System is available in various modular configurations, including rods, rings, and screws, allowing clinicians to customize the setup for different limb sizes and clinical requirements. This flexibility ensures compatibility with a wide range of patients, from pediatric to adult cases, while maintaining precise alignment and stability.

• Can the Arbor External Fixation System be used in patients who require MRI scans, and why is this important?

  Yes, the Arbor External Fixation System is compatible with MRI environments, meaning it can be used in patients who need magnetic resonance imaging during or after treatment. This is important because it avoids the need for additional hardware or delays in monitoring bone healing, while also reducing patient discomfort from multiple procedures.

• How is the Arbor External Fixation System regulated, and what does this mean for clinicians or facilities using it?

  The Arbor External Fixation System is authorized under FDA 510(k) clearance and MDR compliance, meaning it meets stringent regulatory standards for safety and effectiveness as an external fixation device. Clinicians can rely on its compliance with these frameworks, ensuring it adheres to best practices for orthopedic hardware in trauma and reconstructive settings.