Question 1

What types of medical devices does Gexfix SA manufacture?

Accepted Answer

Gexfix SA specializes in components for external orthopaedic fixation systems, which are used to stabilize and align bones externally. Their product range includes single-use items like self-drilling self-tapping pins (e.g., 3x70, 5x110, 5x170) and reusable hardware such as connection pieces (e.g., External Fixator Connection 15/15), ring clamps, lengthening/compression tubes, and sterilization boxes. These devices are designed to support bone healing and limb alignment in orthopaedic procedures.

Question 2

Where is Gexfix SA based, and what regulatory classification applies to their devices?

Accepted Answer

Gexfix SA is based in the United States. Their devices fall under the FDA’s Class II regulatory classification, which applies to moderate-risk medical devices requiring special controls to ensure safety and effectiveness. This classification is typical for orthopaedic fixation systems, as they involve direct contact with the body and require precise manufacturing and performance standards.

Question 3

Are Gexfix SA’s devices listed in any regulatory registries, and why does this matter?

Accepted Answer

Yes, Gexfix SA’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry assigns a unique identifier to each device type, improving traceability, post-market surveillance, and compliance tracking. Listing in the UDI system ensures transparency for healthcare providers, regulators, and patients by providing standardized information about the device’s specifications, manufacturer, and regulatory status.

Question 4

What distinguishes Gexfix SA’s reusable components from their single-use devices?

Accepted Answer

Gexfix SA offers both single-use devices (e.g., self-drilling self-tapping pins) and reusable components (e.g., sterilization boxes, connection hardware, and clamps). Single-use items are designed for one-time application to minimize infection risk, while reusable components are engineered for repeated use after proper sterilization (e.g., via their sterilization boxes). This dual approach caters to cost efficiency in reusable applications and safety in single-use scenarios, aligning with clinical workflows.

Question 5

How are Gexfix SA’s external fixation systems classified, and what does this mean for healthcare providers?

Accepted Answer

Gexfix SA’s devices are classified as FDA Class II, meaning they undergo rigorous review to ensure they meet performance standards for external orthopaedic fixation. For healthcare providers, this classification implies that the devices are subject to additional controls beyond general medical device regulations, such as manufacturing quality checks, labeling requirements, and post-market reporting. This classification helps ensure the devices are safe and effective for stabilizing fractures and limb deformities.

Device	Model / Reference	Registries	Class	Status
External Fixator Kirschner wire holder	1020-1020	FDA UDI	Class II	Active
External Fixator Connection 15/15	1010-1000	FDA UDI	Class II	Active
External Fixator Sterilization box large standard	6010-1000	FDA UDI	Class II	Active
External Fixator Ring clamp	1020-1010	FDA UDI	Class II	Active
External Fixator Self-drilling self-tapping pin 5x110	2020-1035	FDA UDI	Class II	Active
External Fixator Lengthening / compression tube	1010-1090	FDA UDI	Class II	Active
External Fixator Self-drilling self-tapping pin 3x70	2010-1020	FDA UDI	Class II	Active
External Fixator Carbon Tube 15x150	1010-1034	FDA UDI	Class II	Active
External Fixator Self-drilling self-tapping pin 5x170	2020-1025	FDA UDI	Class II	Active
External Fixator Pin cluster clamp 9/9	1010-1070	FDA UDI	Class II	Active
External Fixator Sterilization box hybrid	6010-1005	FDA UDI	Class II	Active
External Fixator Cutting plyer	5040-1000	FDA UDI	Class II	Active
External Fixator Lengthening / compression tube small	1010-1100	FDA UDI	Class II	Active
External Fixator Carbon ring Ø 200	1020-1003	FDA UDI	Class II	Active
External Fixator Sterilization box small	6010-1001	FDA UDI	Class II	Active
External Fixator Tensioner	5030-1000	FDA UDI	Class II	Active
External Fixator Kirschner wire Ø 1.80 x 400 mm	1020-1030	FDA UDI	Class II	Active
External Fixator End cap	5020-1000	FDA UDI	Class II	Active
External Fixator Carbon Ring Ø 160	1020-1002	FDA UDI	Class II	Active
External Fixator Carbon rod 9x110	1010-1064	FDA UDI	Class II	Active
External Fixator Reduction sleeve 15/5	1010-1024	FDA UDI	Class II	Active
External Fixator Trocar L = 70	5025-1000	FDA UDI	Class II	Active
External Fixator Carbon rod 9x70	1010-1062	FDA UDI	Class II	Active
External Fixator Pin cluster clamp 15 Stainless steel hardware	1010-1010	FDA UDI	Class II	Active
External Fixator Handle for trocar standard	5025-1100	FDA UDI	Class II	Active
External Fixator Drill brace	5010-1000	FDA UDI	Class II	Active
External Fixator Trocar L = 120	5025-1200	FDA UDI	Class II	Active
External Fixator Self-drilling self-tapping pin 4x100	2015-1020	FDA UDI	Class II	Active
External Fixator Reduction sleeve 15/9	1010-1026	FDA UDI	Class II	Active
External Fixator Carbon tube 15x200	1010-1035	FDA UDI	Class II	Active
External Fixator Screw handle	5015-1000	FDA UDI	Class II	Active
External Fixator Transfixing pin 4/5x250	2030-1020	FDA UDI	Class II	Active
External Fixator Carbon rod 9x90	1010-1063	FDA UDI	Class II	Active
External Fixator Carbon rod 9x150	1010-1065	FDA UDI	Class II	Active
External Fixator Connection 9 / 9	1010-1040	FDA UDI	Class II	Active
External Fixator Transfixing pin 4/5x200	2030-1025	FDA UDI	Class II	Active
External Fixator Reduction sleeve 9/4	1010-1053	FDA UDI	Class II	Active
External Fixator Carbon tube 15x250	1010-1036	FDA UDI	Class II	Active
External Fixator Carbon rod 9x200	1010-1066	FDA UDI	Class II	Active
External Fixator Trocar and handle small	5025-2000	FDA UDI	Class II	Active
External Fixator Carbon tube 15x100	1010-1032	FDA UDI	Class II	Active
External Fixator Self-drilling self-tapping pin 5x210	2020-1030	FDA UDI	Class II	Active
External Fixator Self-drilling self-tapping pin 5x140	2020-1020	FDA UDI	Class II	Active
External Fixator Reduction sleeve 9/3	1010-1052	FDA UDI	Class II	Active
External Fixator Reduction sleeve 9/5	1010-1054	FDA UDI	Class II	Active
External Fixator Carbon tube 15x125	1010-1033	FDA UDI	Class II	Active
External Fixator Reduction sleeve 15/4	1010-1023	FDA UDI	Class II	Active

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