Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes)

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

Trade Name

Flexigrip

Model / Reference

FG0350

Primary DI / UDI-DI

08033675780245

Basic UDI-DI

803367578FLEXIGRIPTY

510(k) Number

K063009 ↗

FDA Product Code

HRS

EMDN Code

H02010202 Sternal clips

Device Class

Class IIb EUDAMED

Class II 510(k)

Regulation

21 CFR Part 888.3030

EU market of registration

Italy

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• What types of patients is the Flexigrip Sternal Closure System intended to support during sternal closure after surgery?

  The Flexigrip Sternal Closure System is designed for patients who have undergone median sternotomy procedures, such as open-heart surgery. Its flexible, self-locking clips are sized to accommodate varying patient anatomies through models FG0200 to FG0400, ensuring secure sternal edge approximation and alignment to aid proper wound healing.

• How is the Flexigrip Sternal Closure System supplied, and is it reusable?

  The system is supplied sterile and explicitly intended for single-use only, as noted in the manufacturer’s specifications. This ensures patient safety and reduces the risk of infection or cross-contamination between procedures.

• Are there different sizes available, and how do I determine which one to use for a patient?

  Yes, the Flexigrip Sternal Closure System comes in multiple models (FG0200 through FG0400) to match different patient anatomies. The sizing is tailored to accommodate varying sternal widths, but the exact selection should be based on clinical assessment and the specific anatomical requirements of the patient’s sternum post-surgery.

• Can this device be used in an MRI environment, and why is that important?

  Yes, the Flexigrip Sternal Closure System is non-magnetic, making it safe for use in MRI environments. This is particularly important for patients who may require postoperative imaging, as magnetic interference could distort MRI scans or pose safety risks.

• What regulatory pathways does this device follow in the U.S. and Europe, and what does that mean for clinicians?

  In the U.S., the Flexigrip System is cleared under FDA 510(k) (K063009) with a determination of *Substantially Equivalent* to a predicate device, reviewed by the Orthopedic Advisory Committee. In Europe, it complies with the EU Medical Device Regulation (MDR). Clinicians can rely on these clearances as evidence of the device’s safety and performance, though local institutional protocols should still be followed for specific procedures.