Arthrex Low Profile Screws

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

Arthrex EUDAMED

Arthrex® GUDID

Generic Name

Arthrodesis intramedullary nail, non-distracting

Device Name

DualCompression Hindfoot Fusion Nail System

Tibial Nail System

Trochanteric Nail System

Model / Ref / Catalog

AR-9094ES-12-4525L, AR-9096FT-65-035, AR-9090-10S, AR-9094ES-11-4225L, AR-9094ES-14-4230L

Primary DI / UDI-DI

00888867412514, 00888867416185, 00888867305588, 00888867412354, 00888867413054

Basic UDI-DI

0888867HinFtFuNail00000L9, 0888867FemNailSys000000L5, 0888867TroNailSys000000Z7

510(k) Number

K203239 ↗

FDA Product Code

HWC 510(k)

HSB GUDID

EMDN Code

P09120201 Intramedullary nails

GMDN Term

Arthrodesis intramedullary nail, non-distracting

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 888.3040 510(k)

888.3020 GUDID

Market of Registration

Netherlands

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

MRI Safety

MR Conditional

• Arthrex®

  Class IIb

  CE/MDR

• Arthrex

  Class IIb

  CE/MDR

• Arthrex®

  Class IIb

  CE/MDR

• Arthrex®

  Class IIa

  CE/MDR

• Arthrex

  Class IIb

  CE/MDR

• Arthrex

  Class IIb

  CE/MDR

See all devices from Arthrex, Inc. →

• Are these screws reusable, or are they meant for single-use only in orthopedic forefoot procedures?

  These screws are explicitly designed for single-use only, as confirmed by the FDA’s 510(k) clearance (K203239) under the Orthopedic Advisory Committee. The clearance explicitly states no third-party reprocessing authorization is granted, so reuse—even by the original facility—is not permitted to maintain sterility and performance standards. This aligns with standard orthopedic practice for cannulated and solid screw systems in small-fragment fixation.

• What sizes and screw types are included in the Arthrex Low Profile Screws set, and how do they differ for forefoot applications?

  The set includes three screw diameters: 2 mm, 2.3 mm, and 3 mm, each available in cannulated and solid variants, as well as partially threaded options. The cannulated screws allow for over-the-wire insertion, reducing soft-tissue trauma—a key advantage in forefoot procedures where precision and minimal disruption are critical. The partially threaded designs provide controlled purchase without over-compressing small bones, while the solid screws offer maximum stability for load-bearing sites.

• What instruments are provided with the Arthrex Low Profile Screws set, and how do they enhance forefoot fixation?

  The set includes drill bits (1.7 mm, 2.0 mm, 2.3 mm, 2.4 mm) for precise pilot hole creation, a screw depth device to ensure accurate insertion without over-tightening, and AO-compatible screwdrivers for torque control. These tools collectively enable surgeons to achieve minimal invasiveness—critical for forefoot surgeries—and reduce the risk of cortical perforation or screw back-out, which are common challenges in small-bone fixation.

• How should the Arthrex Low Profile Screws be stored to maintain sterility, and what are the implications if protocols aren’t followed?

  The screws must be stored and handled strictly according to sterile medical device protocols, as implied by their single-use designation and the inclusion of complementary sterile instruments. Improper storage—such as exposure to moisture, temperature extremes, or contamination—could compromise sterility, risking infection or device failure. Since the system is not designed for reprocessing, any deviation from sterile handling renders the screws unusable, potentially leading to surgical delays or the need for additional sterile supplies.

• What regulatory pathway was followed for FDA clearance, and how does this affect clinical use in the U.S.?

  The Arthrex Low Profile Screws received FDA 510(k) clearance (K203239) through the Traditional Review pathway, determined to be *substantially equivalent* to a legally marketed predicate device under the Orthopedic Advisory Committee (OR). This clearance confirms the device meets U.S. safety and effectiveness standards for orthopedic fixation in forefoot applications, but it does not imply any specific clinical indication—only that the device’s design and performance were reviewed against established benchmarks. Clinicians should refer to the device labeling for precise surgical techniques.