NexFix Compression Staple

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

510(k) Number

K070688 ↗

FDA Product Code

JDR

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• Futura Biomedical Flexible Great Toe Implant

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• Osteocure Resorbable Bead Kit

  Class II

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• Modification to Classic Great Toe Implant

  Class II

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• Classic Great Toe Implant

  Class II

  FDA 510(k) K023086 Active Cleared 4 Oct 2002

• Subtalar Peg Implant

  Class II

  FDA 510(k) K033046 Active Cleared 23 Dec 2003

See all devices from Nexa Orthopedics, Inc. →

• What types of surgical procedures is the NexFix Compression Staple primarily used for, and why is it considered a bone fixation device?

  The NexFix Compression Staple is primarily used for procedures like bone fusion, osteotomy, or fixation in the hand and foot. It is classified as a bone fixation device because it provides mechanical stability and secure alignment of bone fragments by compressing them together during surgery. This helps maintain proper positioning while the bone heals, reducing the risk of displacement.

• Is the NexFix Compression Staple intended for single-use or reusable applications, and how does this affect its maintenance?

  The NexFix Compression Staple is designed for reusable applications, as indicated by its regulatory submission under the FDA 510(k) pathway. Since it is not described as single-use, proper sterilization and maintenance protocols must be followed to ensure its safety and effectiveness for repeated surgical use. The manufacturer’s instructions (not provided here) should outline cleaning and reprocessing guidelines.

• How many size options are available for the NexFix Compression Staple, and why might this range be important for surgeons?

  The NexFix Compression Staple is supplied in 21 distinct sizes, allowing surgeons to select the appropriate staple for varying bone dimensions and anatomical locations. This range ensures compatibility with different patient anatomies, enhancing precision in fixation during procedures like hand or foot surgeries, where bone sizes can vary significantly.

• What regulatory pathway was followed for the FDA clearance of the NexFix Compression Staple, and what does this mean for its clinical use?

  The NexFix Compression Staple received FDA clearance through the 510(k) pathway (K070688), specifically under a *Traditional* clearance type, meaning it was determined to be *substantially equivalent* to a legally marketed device already on the market. This pathway ensures that the device meets FDA safety and effectiveness standards for bone fixation applications, allowing orthopedic specialists to use it with confidence in procedures like fusion or osteotomy.

• Are there any specific storage requirements mentioned for the NexFix Compression Staple, and what should clinicians consider when handling it?

  The provided data does not explicitly detail storage requirements for the NexFix Compression Staple. However, since it is a reusable surgical instrument, clinicians should follow standard protocols for storing metallic orthopedic tools—such as keeping them in a clean, dry environment and adhering to manufacturer-recommended sterilization procedures—to prevent corrosion or contamination before reuse.