C Fit Cup

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

510(k) Number

K903938 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SN

• Blakemore Retainer

  Class II

  FDA 510(k) K880253 Active Cleared 11 Mar 1988

• Extremity Elevator

  Class I

  FDA 510(k) K870125 Active Cleared 4 Feb 1987

• Tendon Leader

  Not classified

  FDA 510(k) K853764 Active Cleared 7 Oct 1985

• Freeman Total Hip System Ridged Stem

  Class II

  FDA 510(k) K890331 Active Cleared 13 Oct 1989

• Osi Rizzoli Trauma Table (Electric Version)

  Class I

  FDA 510(k) K881060 Active Cleared 25 Mar 1988

• Tlc Support Products

  Not classified

  FDA 510(k) K803029 Active Cleared 22 Dec 1980

See all devices from Orthopedic Systems, Inc. →

• What type of surgical procedure is the C Fit Cup intended for, and how does it function in that context?

  The C Fit Cup is designed specifically for use in total hip arthroplasty procedures, serving as the femoral component of the hip replacement. It acts as a stable interface between the femoral stem and the acetabular component, helping to restore hip function, mobility, and stability by replicating the natural anatomy of the hip joint.

• Is the C Fit Cup intended for reuse in multiple surgeries, or is it meant to be used only once?

  The C Fit Cup is explicitly intended for single-use in orthopedic surgical settings. This is standard practice for surgical implants to ensure patient safety and sterility, as reuse could introduce risks of contamination or mechanical compromise.

• How is the C Fit Cup supplied, and what should clinicians expect when receiving a shipment?

  The C Fit Cup is supplied sterile, meaning it is pre-packaged and ready for immediate surgical use without additional sterilization. Clinicians should expect to receive it in a sterile packaging suitable for surgical environments, ensuring it meets the requirements for aseptic conditions during hip replacement procedures.

• What regulatory pathway was followed for the FDA clearance of the C Fit Cup, and what does this mean for its use?

  The C Fit Cup was cleared through the FDA’s 510(k) pathway under Traditional Review, with a clearance number of K903938. This means it was determined to be substantially equivalent to a legally marketed device already on the market, allowing it to be used in total hip replacement procedures as intended. The clearance was granted by the Orthopedic Advisory Committee.