Vidal Total Hip Prosthesis

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

Full name

Prosthesis, Vidal Total Hip

510(k) Number

K770472 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What types of patients is the Vidal Total Hip Prosthesis designed for, and what conditions does it address?

  The Vidal Total Hip Prosthesis is designed for patients requiring total hip joint replacement due to degenerative joint disease, fractures, or other conditions necessitating arthroplasty. It is a semi-constrained, metal cemented acetabular component intended to restore hip function in these cases. The device is not intended for use in patients who require MRI imaging, as it is not MRI-compatible.

• How is the Vidal Total Hip Prosthesis supplied, and what are the key considerations for its use in surgery?

  The Vidal Total Hip Prosthesis is supplied as a reusable surgical implant, meaning it is intended for single-use per patient and must be discarded after implantation. It requires sterile handling and use in sterile operating environments. Proper surgical technique is essential, including cement fixation to the acetabulum, to ensure correct placement and function.

• What regulatory pathway was followed for the FDA clearance of the Vidal Total Hip Prosthesis, and what does this mean for its use?

  The Vidal Total Hip Prosthesis received FDA clearance through a 510(k) submission (K770472), classified under product code JDL and reviewed by the Orthopedic (OR) Advisory Committee. The device was determined to be substantially equivalent to a legally marketed predicate, meaning it meets FDA standards for safety and effectiveness as a Class III medical device. This clearance does not imply any specific clinical indication beyond what is stated in the device description.

• Are there multiple sizes or models available for the Vidal Total Hip Prosthesis, and how are they identified?

  Yes, the Vidal Total Hip Prosthesis comes in multiple sizes and models, as indicated by the extensive list of FEI numbers (e.g., 3020282716, 3007923096) and registration numbers (e.g., 8043792, 2242737) in the data. These identifiers correspond to distinct acetabular component sizes or variations, which must be selected based on the patient’s anatomy and surgical requirements. The exact sizing details would typically be provided in the manufacturer’s surgical technique guide.

• What storage and handling precautions must be followed for the Vidal Total Hip Prosthesis to maintain sterility?

  Since the Vidal Total Hip Prosthesis is intended for use in sterile operating environments, it must be stored and handled according to standard sterile medical device protocols. This includes proper packaging, protection from contamination, and adherence to manufacturer guidelines for shelf life and expiration. The device should not be reused after implantation, as it is designed for single-use per patient.