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OrthoPak Bone Growth Stimulator System

by Ahp Eos Buyer, Inc.

PMA P850022

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

PMA P850022↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP850022 Date18 Feb 1986DecidedStatusActive

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-1618-2024 FDA Class II initiated 22 Mar 2024
    • Ongoing Z-1619-2024 FDA Class II initiated 22 Mar 2024
    • Ongoing Z-1616-2024 FDA Class II initiated 22 Mar 2024
    • Ongoing Z-1617-2024 FDA Class II initiated 22 Mar 2024

    Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Orthopak(R) Bone Growth Stimulator
Trade Name
Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy
Generic Name
Stimulator, bone growth, non-invasive
PMA Number
FDA Product Code
LOF
Device Class
Class II
Regulation
21 CFR Part 890.5870
Advisory Committee
Orthopedic
FDA Decision
APRL

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The OrthoPak Bone Growth Stimulator System is a non-invasive electrical device classified as a bone growth stimulator. It is designed to promote the healing of fracture nonunions by applying capacitive coupling technology to stimulate bone regeneration without surgical intervention.

This system is intended for use in orthopedic settings and has received FDA Premarket Approval (PMA P850022). It is supplied as a reusable device and is not sterile at time of shipment. The system operates under regulatory classification LOF and adheres to FDA regulation 890.5870. Multiple registration numbers (e.g., 3010032952) are associated with its distribution.

Other devices from Ahp Eos Buyer, Inc.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the OrthoPak Bone Growth Stimulator System and how does it work?

    The OrthoPak Bone Growth Stimulator System is designed to promote the healing of fracture nonunions—a condition where a broken bone fails to heal properly—without requiring surgery. It uses capacitive coupling technology, a non-invasive electrical method, to stimulate bone regeneration by applying controlled electrical impulses to the affected area. This approach helps encourage natural bone growth and healing in orthopedic settings.

  • Is the OrthoPak Bone Growth Stimulator System single-use or reusable, and what does that mean for maintenance?

    The OrthoPak Bone Growth Stimulator System is reusable, meaning it is intended for repeated use across multiple patients after proper cleaning and maintenance. Since it is not sterile at shipment, facilities must follow manufacturer guidelines for disinfection and sterilization between uses to ensure safety and functionality. This design reduces waste and costs over time compared to single-use devices.

  • How is the OrthoPak Bone Growth Stimulator System regulated, and what does that mean for clinicians?

    The OrthoPak Bone Growth Stimulator System holds FDA Premarket Approval (PMA P850022), confirming it meets rigorous standards for safety and effectiveness as a non-invasive bone growth stimulator. Clinicians can rely on this approval to ensure the device adheres to FDA regulations (e.g., 21 CFR 890.5870) and has undergone thorough review by the Orthopedic (OR) Advisory Committee. This classification also means it is subject to ongoing compliance monitoring through the assigned registration numbers (e.g., 3010032952).

  • What storage or handling considerations should be taken for the OrthoPak Bone Growth Stimulator System?

    Since the OrthoPak Bone Growth Stimulator System is not sterile at shipment, it must be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality. Before reuse, the device requires thorough cleaning and disinfection as per the manufacturer’s instructions to prevent contamination. Proper storage also includes keeping cables and electrodes organized to avoid damage, ensuring the system remains operational for subsequent clinical applications.