FMP Metal/Metal Acetabular Insert

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

510(k) Number

K003250 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K931665 Active Cleared 17 Feb 1994

• Berlin External Fixator

  Class II

  FDA 510(k) K954053 Active Cleared 16 May 1996

• Modification to Isobar Spinal System

  Class II

  FDA 510(k) K000020 Active Cleared 3 Feb 2000

• Foundation Knee Augmentation Blocks

  Class II

  FDA 510(k) K941306 Active Cleared 8 Feb 1995

• Foundation Porous Coated Hemispherical Shell

  Class II

  FDA 510(k) K974093 Active Cleared 28 Jan 1998

• Press-Fit Porous Shell

  Class II

  FDA 510(k) K961526 Active Cleared 17 Sep 1996

See all devices from Encore Orthopedics, Inc. →

• What types of hip surgeries is the FMP Metal/Metal Acetabular Insert designed for, and why is the metal-on-metal bearing surface significant?

  The FMP Metal/Metal Acetabular Insert is specifically designed for total hip arthroplasty (replacement surgery) to replace a damaged acetabulum. The metal-on-metal bearing surface reduces friction and wear between the acetabular component and the femoral head, which can improve longevity and stability of the hip prosthesis. This design choice is particularly relevant for patients requiring durable, low-friction bearings, though it requires careful surgical planning and patient selection.

• How many sizes and configurations are available for the FMP Metal/Metal Acetabular Insert, and how do I determine the correct size for a patient?

  The FMP Metal/Metal Acetabular Insert comes in multiple sizes and configurations, each identified by a unique FEI number (e.g., 3020282716, 3007923096, etc.). The correct size is determined by the surgeon based on the patient’s anatomy, acetabular dimensions, and clinical needs. Preoperative imaging (like CT or MRI scans) is typically used to measure the acetabulum, and the surgeon selects the appropriate insert size to ensure proper fit and function during the procedure.

• Is the FMP Metal/Metal Acetabular Insert reusable, or is it intended for single-use only? What does this mean for surgical planning?

  The FMP Metal/Metal Acetabular Insert is explicitly intended for single-use only and is supplied sterile. This means each insert is designed for one surgical procedure and must not be reused, even after sterilization. Surgical planning must account for this, as hospitals or clinics will need to ensure an adequate supply of sterile inserts is available for each case to avoid delays or contamination risks.

• What storage requirements should I follow for the FMP Metal/Metal Acetabular Insert to maintain its sterility and integrity?

  Since the FMP Metal/Metal Acetabular Insert is supplied sterile, it must be stored in its original packaging until use to preserve sterility. The packaging should remain unopened and undamaged, protected from moisture, extreme temperatures, and direct sunlight. Follow the manufacturer’s instructions for storage conditions, typically outlined in the accompanying documentation, to ensure the device remains safe and effective for its intended single-use procedure.

• How do I confirm the regulatory clearance status of the FMP Metal/Metal Acetabular Insert before purchasing or using it?

  The FMP Metal/Metal Acetabular Insert has received FDA 510(k) clearance, which means it has been determined to be substantially equivalent to a legally marketed device. To confirm its regulatory status, you can reference the 510(k) number (K003250) or check the FDA’s open database (OpenFDA) using the listed FEI numbers or the registration number (8043792). Always verify compliance with local regulations and consult the manufacturer’s documentation for additional details.