Secur-Fit HA PSL Extra Acetabular Component System

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

Full name

Osteonics Secur-Fit Ha Psl Extra Acetabular Component System

510(k) Number

K954023 ↗

FDA Product Code

MEH

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Osteonics(R) Omnifit(R) Normalized Hip Stem

  Class II

  FDA 510(k) K932519 Active Cleared 10 Mar 1994

• Omnifit II Hip Prostheses: Cement Fixation

  Class II

  FDA 510(k) K870235 Active Cleared 29 May 1987

• Osteonics Total Elbow System Open recall

  Class II

  FDA 510(k) K980502 Active Cleared 5 May 1998

• MC2P Acetabular Component Open recall

  Class II

  FDA 510(k) K900438 Active Cleared 18 Apr 1990

• Shoulder Microstructured Humeral Prosthesis

  Class II

  FDA 510(k) K883816 Active Cleared 10 Nov 1988

• Osteonics(R) Mpss Hip Stem Series

  Class II

  FDA 510(k) K905275 Active Cleared 28 Jan 1991

See all devices from Osteonics Corp. →

• What is the Secur-Fit HA PSL Extra Acetabular Component System used for?

  This system is designed specifically for hip arthroplasty (total hip replacement) procedures. The porous-coated, hydroxyapatite (HA) shell promotes osseointegration—direct bone growth into the implant—without requiring bone cement, ensuring stable fixation in the acetabulum. The modular components, including a metal shell and optional cementable polyethylene insert, allow customization for optimal joint articulation and longevity.

• How is the Secur-Fit HA PSL Extra system supplied, and what does it include?

  The system is supplied as a modular orthopedic implant kit for total hip replacement. It includes a porous-coated, hydroxyapatite-coated acetabular shell for cementless fixation, a metal shell, a cementable polyethylene insert (for added stability if needed), and a ceramic-on-ceramic bearing option. These components are engineered to work together for reduced wear and improved joint function.

• Is the Secur-Fit HA PSL Extra Acetabular Component System sterile and single-use?

  Yes, the device is sterile and intended for single-use in a controlled surgical setting. Sterility is critical for preventing infection during hip arthroplasty, and single-use ensures compliance with medical device regulations while maintaining implant integrity. Reuse is not recommended due to potential contamination and degradation of performance.

• Can this acetabular component be used with any femoral head, or are there compatibility requirements?

  The system is designed to articulate with compatible femoral heads to ensure optimal biomechanical function. While the modular design allows flexibility, the manufacturer specifies that the femoral head must match the system’s design parameters for proper fit and articulation. This minimizes impingement and maximizes joint stability and longevity.

• What storage and handling precautions should be taken for this implant?

  The Secur-Fit HA PSL Extra system must be stored in its original sterile packaging until use, in a clean, dry environment protected from moisture, dust, and extreme temperatures. Handling should be done with sterile gloves in a controlled surgical setting to prevent contamination. Once opened, the implant should be used immediately to maintain sterility and performance integrity.