Dall-Miles Suture/Beaded Cable

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

510(k) Number

K953818 ↗

FDA Product Code

JDQ

Device Class

Class II

Regulation

21 CFR Part 888.3010

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What types of orthopedic procedures is the Dall-Miles Suture/Beaded Cable specifically designed for?

  The Dall-Miles Suture/Beaded Cable is designed for procedures requiring reinforcement and stability, such as trochanteric reattachment or cerclage fixation in orthopedic surgery. Its combination of suture and beaded cable provides added support during these specific surgical applications.

• Is the Dall-Miles Suture/Beaded Cable intended for reuse, or is it meant to be used only once?

  The device is explicitly labeled for single-use only in orthopedic surgery. This ensures patient safety and sterility, as reuse could compromise integrity and introduce infection risks. Always follow sterile handling protocols before use.

• How should the Dall-Miles Suture/Beaded Cable be stored to maintain its sterility?

  Since it is supplied sterile, storage must adhere to standard sterile medical device protocols. Keep the packaging intact and sealed until immediately before use, and avoid exposure to moisture, heat, or contamination. Check expiration dates and storage conditions as directed by the manufacturer.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Dall-Miles Suture/Beaded Cable received FDA 510(k) clearance (K953818) under the Traditional review pathway, with a decision classification of *Substantially Equivalent* to a predicate device. This means it was determined to have the same intended use and technological characteristics as a previously cleared device, ensuring compliance with FDA standards for orthopedic cerclage/fixation applications.

• Are there different sizes or models available for the Dall-Miles Suture/Beaded Cable, or is it supplied in a single configuration?

  The provided data does not specify multiple sizes or models—only that it is a single device type (cerclage fixation suture/beaded cable). For exact sizing or variations, refer to the manufacturer’s packaging or technical documentation, as orthopedic procedures may require tailored lengths or cable diameters.