Self-Aligning Acetabular Component

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

510(k) Number

K831792 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• New Jersey Femoral Stem

  Class II

  FDA 510(k) K842234 Active Cleared 20 Jul 1984

• New Jersey Acetabular Component &

  Class II

  FDA 510(k) K842202 Active Cleared 20 Jul 1984

• New Jersey Femoral Resurfacing Component

  Class II

  FDA 510(k) K842233 Active Cleared 20 Jul 1984

• What types of hip surgeries is this acetabular component designed for, and why is the semi-constrained design important?

  This Self-Aligning Acetabular Component is specifically designed for total hip arthroplasty (replacement surgery) to replace a damaged or diseased acetabulum. The semi-constrained design provides a balance between stability and controlled motion, reducing the risk of dislocation—a common complication in hip replacements—while still allowing natural movement of the femoral head.

• Is this device reusable or intended for single-use, and how should it be handled to maintain sterility?

  The Self-Aligning Acetabular Component is intended for single-use only in sterile surgical environments. Since it is metal and cemented, it must be handled under aseptic protocols to preserve sterility before implantation. Improper reuse or contamination could compromise patient safety and device integrity.

• What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical settings?

  This device received FDA 510K clearance under the Traditional pathway, determined to be *substantially equivalent* to predicate devices. It is classified as Class III, meaning it underwent rigorous review by the Orthopedic (OR) Advisory Committee. Clinically, this clearance confirms its compliance with safety and performance standards for use in total hip arthroplasty, ensuring it meets FDA’s requirements for metal cemented acetabular components.

• Are there different sizes or models available, and if so, how would a surgeon determine the correct fit for a patient?

  While the provided data does not specify exact sizes or model variations, the Self-Aligning Acetabular Component is designed to accommodate standard acetabular dimensions used in total hip replacements. Surgeons typically select the appropriate size based on preoperative imaging (e.g., CT or X-ray) and intraoperative assessment to ensure proper alignment and stability of the femoral head. The self-aligning feature helps mitigate placement errors, but precise sizing remains critical.