Dall Miles System Minicleat

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

510(k) Number

K934058 ↗

FDA Product Code

JDQ

Device Class

Class II

Regulation

21 CFR Part 888.3010

Advisory Committee

Orthopedic

FDA Decision

SN

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• What types of long bone fractures is the Dall Miles System Minicleat designed to stabilize, and how does it achieve this?

  The Dall Miles System Minicleat is specifically designed for internal fixation of long bone fractures, meaning it is used inside the body to hold broken bone segments together. It achieves stabilization by providing structural support and proper alignment during the healing process, ensuring the bone remains in the correct position while it knits back together.

• Is the Dall Miles System Minicleat intended for single-use or reusable applications, and what does this mean for surgical workflows?

  The Dall Miles System Minicleat is supplied as a reusable orthopedic implant system. This means it is intended to be sterilized and used multiple times across different patients, which can streamline surgical workflows by reducing the need for single-use implants. However, proper sterilization protocols must be followed to ensure patient safety between uses.

• How is the Dall Miles System Minicleat regulated, and what does its FDA clearance indicate about its intended use?

  The Dall Miles System Minicleat received FDA clearance under the Traditional 510(k) pathway in 1994 with clearance number K934058 and product code JDQ. This indicates that the device was determined to be substantially equivalent to a legally marketed predicate device for certain orthopedic fracture fixation applications. The clearance does not specify additional details like sterility or MRI safety, so clinicians should confirm compatibility with their specific surgical needs.

• What does the advisory committee classification (OR) mean for the Dall Miles System Minicleat, and how does it relate to its use in surgery?

  The advisory committee classification OR (Orthopedic) for the Dall Miles System Minicleat indicates that its review was handled by the Orthopedic Devices Panel of the FDA. This panel specializes in evaluating orthopedic implants, including fixation devices for bone fractures. While the classification itself doesn’t define clinical indications, it confirms the device’s focus on orthopedic surgical applications, particularly for stabilizing long bone fractures.