Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)

• 19 recalls, same reason

  • Ongoing Z-0377-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0384-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0382-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0385-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0387-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0375-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0373-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0379-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0381-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0371-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0378-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0374-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0370-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0383-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0376-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0386-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0380-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0388-2024 FDA Class II ·initiated 9 Oct 2023
  • Ongoing Z-0372-2024 FDA Class II ·initiated 9 Oct 2023

  Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

• • Terminated Z-0519-2020 FDA Class II ·initiated 21 Aug 2019 ·on shared 510(k) K062998

  Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

• • Terminated Z-0553-2019 FDA Class II ·initiated 24 Oct 2018 ·on shared 510(k) K062998

  Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K062998 ↗

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) K211729 Active Cleared 4 Nov 2021

• Modular Hybrid Glenoid

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  FDA 510(k) K060694 Active Cleared 11 Dec 2006

• Altra Press-Fit Hip System

  Class III

  FDA 510(k) K063002 Active Cleared 31 Oct 2006

• Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument Kits

  Class II

  FDA 510(k) K141219 Active Cleared 18 Jul 2014

• Biomet Headless Compression and Twist-off Screws

  Class II

  FDA 510(k) K142658 Active Cleared 13 Nov 2014

• ExpressBraid Graft Manipulation

  Class II

  FDA 510(k) K152868 Active Cleared 8 Feb 2016

See all devices from Biomet Manufacturing Corp →

• What types of femoral defects is this system specifically designed to address in orthopedic surgery?

  This system is designed for segmental femoral defects, where portions of the femur require structural replacement to restore hip joint function. The modular, press-fit design of the Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug) provides targeted support in cases where bone integrity is compromised, ensuring stability and alignment during hip reconstruction.

• How is the device supplied, and is it intended for single-use or reusable applications?

  The Compress Segmental Femoral Replacement System is supplied as a reusable medical device, meaning it is engineered for multiple surgical uses under proper cleaning, sterilization, and maintenance protocols. This design aligns with its classification as a Class III device under FDA regulations, where durability and reprocessing standards are critical for orthopedic implants.

• What determines the size or configuration of the prosthesis, and how many variations are available?

  The system includes multiple sizes and configurations, each identified by unique FEI numbers (e.g., 3020282716, 3007923096, etc.). These variations accommodate different anatomical requirements for segmental femoral defects, ensuring a precise fit for patients. The modular design allows surgeons to select the appropriate spindle and anchor plug combination based on the specific defect and patient anatomy.

• Is there any information provided about how the device should be stored or handled to maintain its integrity?

  While the provided data does not specify storage conditions or handling instructions in detail, the device adheres to regulatory standards for uncemented acetabular components, which typically require protection from contamination, moisture, and physical damage. Standard orthopedic inventory practices—such as sterile packaging, controlled humidity, and temperature—should be followed to preserve its functionality for reuse.