Biomet Bhs- Mini

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

Trade Name

Biomet(R) EBI BONE Healing System

Generic Name

Stimulator, bone growth, non-invasive

PMA Number

P790002 ↗

FDA Product Code

LOF

Device Class

Class II

Regulation

21 CFR Part 890.5870

Advisory Committee

Orthopedic

FDA Decision

APRL

• OrthoPak Bone Growth Stimulator System Open recall

  Not classified

  FDA PMA P850022 Active Approved 18 Feb 1986

• Osteostim Implantable Bone Growth Stimulator

  Class III

  FDA PMA P790005 Active Approved 25 Jan 1980

• Spinal Fusion Stimulator

  Class III

  FDA PMA P850035 Active Approved 30 Apr 1987

• What is the primary purpose of the Biomet BHS-Mini device, and how does it work?

  The Biomet BHS-Mini is a non-invasive bone growth stimulator designed to promote bone healing and regeneration. It achieves this through electrical stimulation, which helps accelerate the treatment of orthopedic conditions like fractures or delayed unions. The device is classified as a Class II medical device and is intended for use in clinical settings to aid in skeletal recovery.

• Is the Biomet BHS-Mini device single-use or reusable, and what does this mean for its maintenance?

  The Biomet BHS-Mini is supplied as a reusable device, meaning it is intended for repeated use in clinical settings. Since it is not single-use, proper cleaning, maintenance, and sterilization protocols must be followed to ensure its continued safe and effective operation. No specific sterility information is provided, so facility protocols should align with standard practices for reusable medical devices.

• How is the regulatory approval process for the Biomet BHS-Mini structured, and what does this imply for its use?

  The Biomet BHS-Mini received FDA Premarket Approval (PMA P790002), which means it underwent a rigorous review process to demonstrate safety and effectiveness before being authorized for clinical use. This approval route is typically reserved for higher-risk devices, ensuring that the device meets stringent standards for promoting bone healing through non-invasive electrical stimulation. The device is classified under regulatory framework 890.5870.

• What types of orthopedic conditions is the Biomet BHS-Mini intended to assist with, and in what setting is it used?

  The Biomet BHS-Mini is specifically designed to assist with bone healing and regeneration in orthopedic conditions such as fractures or delayed unions. It is intended for use exclusively in clinical settings, where healthcare professionals can monitor and manage patient care effectively. The device is not intended for home use or self-administration.

• Are there any specific storage requirements or considerations for the Biomet BHS-Mini device?

  While the provided data does not specify storage requirements, as a reusable medical device, the Biomet BHS-Mini should be stored in a clean, dry environment to prevent contamination or damage. It should also be kept in a secure location to avoid exposure to extreme temperatures or physical stress. Follow manufacturer guidelines or facility protocols for optimal storage and handling.