Laki Hand Fixation System, Model TFX.3X.06.X

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

510(k) Number

K082679 ↗

FDA Product Code

JEC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• Is the Laki Hand Fixation System reusable or single-use, and how does this affect its use in surgery?

  The Laki Hand Fixation System, Model TFX.3X.06.X, is explicitly designed as a reusable medical device. This means it is intended to be sterilized and reused multiple times in orthopedic surgical settings, provided proper cleaning and sterilization protocols are followed. Its reusable nature allows for cost-effective use across multiple procedures while maintaining sterility and compatibility for surgical environments.

• What types of hand injuries or conditions is this fixation system primarily intended to address?

  The system is designed to stabilize hand fractures, promote bone regeneration in cases of pseudoarthrosis (failed bone healing), and assist in limb lengthening through internal fixation. It uses modular rods and locking nuts to provide targeted stabilization for complex hand trauma or deformities requiring precise alignment.

• How is the Laki Hand Fixation System supplied, and what considerations should be made for storage?

  The system is supplied as a reusable orthopedic fixation device, meaning it is not pre-packaged for single-use. Since it is intended for surgical reuse, storage must comply with sterilization protocols to prevent contamination. Facilities should store it in a clean, dry environment, away from direct sunlight or corrosive agents, and follow manufacturer guidelines for cleaning and sterilization between uses.

• Does this device have any specific compatibility or safety notes for imaging procedures like MRI?

  The provided data does not specify MRI safety information for the Laki Hand Fixation System. Clinicians should exercise caution when considering imaging procedures involving magnetic fields, as metallic orthopedic hardware may pose risks in MRI environments. Always verify compatibility with your imaging facility’s protocols before use.