Porous Coated Acetabular Cup

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K873585 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SN

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

• What is the primary purpose of the Porous Coated Acetabular Cup in hip replacement surgery?

  The Porous Coated Acetabular Cup is designed to provide structural support within the pelvis during total hip arthroplasty. Its porous coating promotes osseointegration—meaning it encourages bone to grow into the cup—enhancing long-term stability and integration with the pelvic bone. This helps ensure the implant remains securely fixed after surgery.

• Is the Porous Coated Acetabular Cup intended for single-use or can it be reused after proper processing?

  The device is explicitly labeled as a reusable implant, meaning it can be sterilized and reused following strict sterile processing protocols. However, reuse requires adherence to rigorous cleaning and sterilization standards to maintain safety and functionality before implantation.

• How was the Porous Coated Acetabular Cup approved by the FDA, and what does that mean for its use?

  The device was cleared under the FDA’s 510(k) pathway as *substantially equivalent* to a predicate device for some indications (decision code: SN). This means it was determined to have the same intended use and technological characteristics as a previously approved device, allowing it to enter the market without demonstrating full clinical efficacy for all possible applications. Its clearance date is October 28, 1987.

• What regulatory committee oversees the Porous Coated Acetabular Cup, and what does that imply for its development?

  The device falls under the jurisdiction of the Orthopedic Advisory Committee (OR) within the FDA’s review process. This committee provides expert guidance on orthopedic implants, including acetabular components, ensuring that safety, performance, and clinical rationale align with established standards for hip replacement systems.