AxSOS Locked Plating 4.0MM Locking Inserts

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

510(k) Number

K110176 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What types of fractures are these locking inserts specifically designed to stabilize with the AxSOS Locked Plating System?

  The AxSOS Locked Plating 4.0mm Locking Inserts are designed to secure locking plates for internal fixation of long bone fractures, particularly at the distal radius, proximal humerus, distal tibia, proximal tibia, and distal femur. They provide stable fixation to help support bone alignment during the healing process for these common fracture sites.

• Are these locking inserts intended for reuse, or are they meant to be used only once? How should they be handled after opening?

  These inserts are explicitly intended for single-use only and are supplied sterile. Once opened, they should not be reused to maintain sterility and ensure patient safety. Proper infection control protocols should be followed, including discarding any unused inserts after opening the packaging.

• What size or diameter are these locking inserts, and how do they fit into the broader AxSOS system?

  The AxSOS Locked Plating 4.0mm Locking Inserts have a 4.0mm diameter, which matches the design of the AxSOS Locked Plating System. They are used in conjunction with compatible plates to provide secure fixation for fractures, ensuring stable alignment during bone healing.

• How are these inserts regulated in the U.S., and what does the FDA’s classification mean for their use?

  These inserts are regulated under the Orthopedic Advisory Committee (OR) classification and received FDA 510(k) clearance (K110176) as substantially equivalent to a predicate device. This means they meet FDA standards for safety and effectiveness for their intended use in internal fixation of long bone fractures, as outlined in the submission.

• What storage conditions should be followed for these sterile locking inserts before use?

  Since these inserts are supplied sterile, they should be stored in their original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain unopened until immediately before use to preserve sterility and prevent contamination.