Modified Freeman Acetabular Cup

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K902110 ↗

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 Turnkey Intergration USA, Inc. →

• What types of hip surgeries is the Modified Freeman Acetabular Cup designed for, and how does its semi-constrained design benefit patients?

  The Modified Freeman Acetabular Cup is specifically designed for total hip arthroplasty, serving as a replacement for the natural acetabulum to provide a stable bearing surface for femoral components. Its semi-constrained design offers increased stability compared to fully unconstrained cups, which can help reduce dislocation risks while still allowing for natural hip movement. This makes it suitable for patients requiring a balance of stability and flexibility in their hip replacement.

• How many sizes and variants of the Modified Freeman Acetabular Cup are available, and how does this variety help surgeons?

  The device comes in multiple sizes and variants, as indicated by the extensive list of registration numbers (e.g., 3020282716, 3007923096, etc.). This variety allows surgeons to select the most appropriate cup size and orientation for each patient’s anatomy, improving fit, stability, and long-term outcomes. The range ensures compatibility with diverse patient morphologies and surgical preferences.

• Is the Modified Freeman Acetabular Cup intended for reuse, or is it strictly single-use? How does this affect surgical workflow?

  The device is explicitly supplied sterile for single-use only, as noted in the description. This ensures patient safety by preventing cross-contamination and reduces the need for reprocessing, streamlining surgical workflows. Single-use also eliminates the risk of sterilization-related damage to the component, maintaining its structural integrity for the procedure.

• What storage requirements should be followed for the Modified Freeman Acetabular Cup to maintain its sterility and performance?

  While specific storage instructions aren’t detailed in the data, the device is supplied sterile for single-use, so it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper handling before surgery—such as avoiding contamination or exposure to moisture—is critical to preserve sterility and functionality until use.

• What regulatory pathway was followed for FDA clearance of the Modified Freeman Acetabular Cup, and what does this mean for clinicians?

  The device received FDA 510(k) clearance (K902110) under a traditional review pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared hip prosthesis, ensuring it meets safety and effectiveness standards. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though they should always follow manufacturer guidelines and institutional protocols for use.