P.F.C. Apical Plug

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K944769 ↗

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

• What is the primary purpose of the P.F.C. Apical Plug in hip replacement surgery?

  The P.F.C. Apical Plug is designed to secure acetabular components during total hip arthroplasty, specifically in cemented hip replacements. It acts as a fixation device to improve stability and integration of the acetabular cup within the pelvic bone, helping to ensure long-term stability of the implant.

• How many different sizes or configurations are available for the P.F.C. Apical Plug, and how are they identified?

  The P.F.C. Apical Plug comes in multiple sizes and configurations, each identified by a unique FEI (Federal Equipment Identifier) number. Over 50 distinct FEI numbers are listed, such as 3020282716, 3007923096, and 1818910, ensuring compatibility with various acetabular cup systems in orthopedic procedures.

• Is the P.F.C. Apical Plug intended for reuse, or is it meant to be used only once?

  The P.F.C. Apical Plug is explicitly intended for single-use only in orthopedic surgical settings. It is supplied sterile and must be handled under aseptic conditions prior to implantation, meaning it cannot be reused after a single procedure.

• What regulatory pathway was followed for FDA clearance of the P.F.C. Apical Plug?

  The P.F.C. Apical Plug received FDA 510(k) clearance through the Traditional Review pathway, demonstrating substantial equivalence to a predicate device. The submission was reviewed by the Orthopedic (OR) Advisory Committee and classified as a Class III medical device under FDA regulations, reflecting its critical role in hip arthroplasty.

• How should the P.F.C. Apical Plug be stored before use to maintain sterility?

  Since the P.F.C. Apical Plug is supplied sterile, it must be stored and handled under aseptic conditions to preserve sterility. The packaging should remain intact until immediately before use, and any exposure to non-sterile environments (e.g., open shelves, contaminated surfaces) should be avoided to prevent contamination.