Arcos Interlocking Distal Stems

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

510(k) Number

K100469 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Biomet Manufacturing Corp →

• Are the Arcos Interlocking Distal Stems designed for single-use or can they be reused in multiple procedures?

  The Arcos Interlocking Distal Stems are explicitly labeled as reusable medical devices in the provided data. This means they are intended for multiple uses in orthopedic procedures, provided they are handled and sterilized according to standard surgical protocols for hip replacement implants. Reuse must comply with manufacturer guidelines and regulatory requirements to ensure patient safety and device integrity.

• What types of sterility precautions should be taken when handling these stems, and why?

  The Arcos Interlocking Distal Stems must be handled in sterile conditions, as indicated in the data. This is because they are metallic implants used in hip arthroplasty, where contamination could compromise patient safety. Sterility is critical to prevent infection and ensure the device’s structural integrity during surgery. Always follow Biomet’s sterilization instructions and adhere to standard surgical aseptic techniques.

• How many sizes or variants of the Arcos Interlocking Distal Stems are available, and how are they identified?

  The Arcos Interlocking Distal Stems come in multiple sizes and variants, each identified by unique FEI numbers (e.g., 3020282716, 3007923096, etc.). The data lists over 50 distinct FEI numbers, which correspond to different stem designs or dimensions. These identifiers help surgeons select the appropriate size for the patient’s anatomy and surgical needs.

• What regulatory pathway was followed for FDA clearance of these stems, and what does that mean for clinicians?

  The Arcos Interlocking Distal Stems were cleared through the FDA 510(k) process (K100469) under the Traditional Review pathway, classified as Class III orthopedic prostheses. This means the device was determined to be substantially equivalent to a legally marketed predicate, ensuring it meets FDA safety and effectiveness standards for semi-constrained, uncemented acetabular components. Clinicians can rely on this clearance as evidence of regulatory scrutiny for use in hip arthroplasty.