Dorr Hip Prosthesis Acetabular Component

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

Full name

Dorr Hip Prosthesis, Acetabular Compon

510(k) Number

K842893 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Minature Pressure Transducer

  Class II

  FDA 510(k) K834040 Active Cleared 10 Feb 1984

• Hydroxylapatite Alveolar Ridge Main

  Class II

  FDA 510(k) K810382 Active Cleared 20 Mar 1981

• Valve Sizer

  Class I

  FDA 510(k) K934951 Active Cleared 10 Dec 1993

• Pyrolite Carbon Alveolar Mainten Implant

  Class II

  FDA 510(k) K791416 Active Cleared 9 Oct 1979

• Carbomedics Supra-Annular Valve Sizer

  Class I

  FDA 510(k) K952184 Active Cleared 29 Nov 1995

• Carbomedics Mitral Rotator

  Class I

  FDA 510(k) K960923 Active Cleared 29 Apr 1996

See all devices from Carbomedics, Inc. →

• What types of patients is the Dorr Hip Prosthesis Acetabular Component designed for?

  The Dorr Hip Prosthesis Acetabular Component is specifically designed for patients requiring total hip arthroplasty due to degenerative joint disease, trauma, or other conditions causing hip dysfunction. It provides a stable metal bearing surface for femoral components and is intended to replace the acetabulum when natural joint function is compromised.

• Is the Dorr Hip Prosthesis Acetabular Component reusable or single-use?

  The Dorr Hip Prosthesis Acetabular Component is supplied as a reusable surgical implant. It is intended for use in orthopedic operating rooms under sterile conditions, meaning it is sterilized and prepared for repeated surgical use following proper protocols.

• How is the Dorr Hip Prosthesis Acetabular Component secured in place during surgery?

  The acetabular component is cemented in place using bone cement, which ensures a stable fixation within the patient’s pelvis. This method is standard for metal cemented acetabular cups like this one.

• What regulatory pathway was followed for the FDA clearance of this device?

  The Dorr Hip Prosthesis Acetabular Component received FDA clearance through a 510(k) submission (K842893) filed in 1984 under the Traditional 510(k) Review pathway. It was determined to be substantially equivalent to a legally marketed predicate device and falls under the Orthopedic advisory committee category, classified as a Class III medical device.

• Where can I find more details about the regulatory history or associated registration numbers?

  The device has multiple FDA registration numbers (e.g., 8043792, 3020282716) and FEI numbers (e.g., 3007923096) listed under its regulatory record. These identifiers can be used to look up detailed submission history, manufacturing site information, and compliance data in the FDA’s OpenFDA database or through official FDA search tools.