Capitello-Condylar Total Elbow Prosthesis

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

510(k) Number

K983141 ↗

FDA Product Code

JDB

Device Class

Class II

Regulation

21 CFR Part 888.3160

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Johnson & Johnson Professionals, Inc. →

• What types of patients is the Capitello-Condylar Total Elbow Prosthesis designed to help, and why is it preferred in those cases?

  This prosthesis is designed for patients with severe degenerative joint disease, such as rheumatoid arthritis, who experience significant pain and functional impairment in their elbow. It is preferred in these cases because it replaces the damaged articular surfaces while preserving existing bone structure, restoring function and relieving pain through total elbow arthroplasty. The semi-constrained design provides stability during movement, making it suitable for patients who require improved mobility and pain relief.

• Is the Capitello-Condylar Total Elbow Prosthesis intended for reuse, or is it meant to be used only once per patient?

  The Capitello-Condylar Total Elbow Prosthesis is explicitly supplied as a sterile, single-use implant. This means each device is intended for one surgical procedure per patient and should not be reused, as reuse could compromise sterility and patient safety. The design and regulatory classification align with single-use orthopedic implants.

• How is the Capitello-Condylar Total Elbow Prosthesis secured in place during surgery, and what postoperative care considerations should be noted?

  The prosthesis is secured in place using bone cement, which is applied during the open surgical procedure. No additional external fixation beyond standard postoperative care is required. This method ensures stability while allowing for natural joint movement post-surgery. Patients will follow typical recovery protocols for elbow arthroplasty, including physical therapy and gradual weight-bearing restrictions.

• What regulatory pathway was followed for FDA clearance of the Capitello-Condylar Total Elbow Prosthesis, and what does this mean for clinicians?

  The device received FDA clearance under a Traditional 510(k) pathway, with a decision dated November 6, 1998. This means the manufacturer demonstrated that the prosthesis is substantially equivalent to a legally marketed predicate device (a previously cleared elbow prosthesis) in terms of safety and effectiveness. Clinicians can rely on this clearance as evidence of the device’s regulatory review, though individual surgical decisions should still align with patient-specific needs and clinical guidelines.

• Are there multiple sizes or models of the Capitello-Condylar Total Elbow Prosthesis, and how might a surgeon determine the correct fit for a patient?

  While the provided data does not specify exact sizing details, the openfda registration numbers and product code (JDB) indicate multiple variants (likely sizes or configurations) have been tracked under this classification. Surgeons typically determine the correct fit through preoperative imaging (e.g., X-rays or CT scans) to assess bone dimensions and joint alignment. Intraoperative templating or trial reductions may also guide selection during surgery to ensure proper articulation and stability.