Bone Screws

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

510(k) Number

K990351 ↗

FDA Product Code

HWC

FDA applicant

Bregma International Trading Company , Ltd.

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Stainless Steel Soft Suture Wire

  Class II

  FDA 510(k) K990355 Active Cleared 8 Jul 1999

• Stainless Steel Fixation Pins

  Class II

  FDA 510(k) K990353 Active Cleared 1 Jun 1999

• Are these bone screws meant for single-use or can they be reused in multiple procedures?

  These bone screws are explicitly labeled as a reusable medical device. Since they are classified under FDA 510(k) clearance (K990351) and designed for orthopedic fixation, they are intended to be cleaned, sterilized, and reused for subsequent surgical procedures, provided proper reprocessing protocols are followed.

• What types of bone fractures or defects are these screws intended to stabilize?

  The Bone Screws are orthopedic fixation devices designed to stabilize and secure bone fragments during surgical procedures. They ensure proper alignment and healing of fractures or bone defects, though the exact clinical applications are not specified beyond their role in orthopedic stabilization. Always refer to surgical guidelines for specific use cases.

• How are these screws supplied, and do they come in different sizes or models?

  The provided data does not specify exact sizes or models, but as Bone Screws (product code HWC), they are likely available in a range of standard orthopedic fixation sizes. Since they are reusable and intended for orthopedic use, they would typically be packaged in sterile or non-sterile sets depending on the manufacturer’s reprocessing instructions. For precise sizing details, contact the manufacturer directly.

• Is there any information about how these screws should be stored before use?

  The data does not provide explicit storage instructions for these reusable bone screws. However, as reusable medical devices, they should be stored in a clean, dry environment to prevent contamination before reprocessing. For proper sterilization and handling protocols, refer to the manufacturer’s reprocessing guidelines or regulatory compliance standards.

• What regulatory pathway was followed for FDA clearance, and what does that mean for their use?

  These Bone Screws received FDA 510(k) clearance (K990351) under the Traditional 510(k) Review pathway, determined to be substantially equivalent to predicate devices. This means they meet FDA standards for safety and effectiveness as orthopedic fixation screws (product code HWC) and are classified under Class II – Special Controls, requiring compliance with additional regulatory requirements beyond general controls.