Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantAhp Eos Buyer, Inc.
1 Gatehall Dr.
Suite 303
Parsippany, NJ 07054
PMA NumberP850022
Supplement NumberS016
Date Received02/06/2006
Decision Date07/27/2006
Reclassified Date05/18/2026
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING DEVICE MODIFICATIONS: 1) THE STIMULATOR HAS BEEN MODIFIED TO INCLUDE: A) A NEW USER INTERFACE (SIMILAR TO P850022/S015). THE USER INTERFACE INCLUDES AN ALARM BUTTON, YELLOW LED, AND A LCD DISPLAY TO INDICATE TREATING STATUS; B) AN AUDIBLE AND VISIBLE SELF-CHECKING ALARM MECHANISM WITH ADDITIONAL MALFUNCTION SOURCE INDICATORS (SAME AS P850022/S015). THE AUDIBLE ALARM MECHANISM CAN BE DISABLED USING THE ALARM BUTTON; C) A NEW MAIN PCB CIRCUIT BOARD (SAME AS P850022/S015); D) SOFTWARE C PROGRAM LANGUAGE (SAME AS P850022/S015); E) AN ELAPSED TIME ACCUMULATOR/PATIENT MONITORING FUNCTION (SIMILAR TO P850022/S015). AFTER 270 DAYS OF ELAPSED TREATMENT TIME OR 400 DAYS OF TOTAL ACTIVATION TIME THE 7UNIT WILL NO LONGER GENERATE A SIGNAL. 2) THE POWER SOURCE HAS BEEN MODIFIED FROM A DISPOSABLE BATTERY TO A RECHARGEABLE NIMH "AA" BATTERY. THE DEVICE INCLUDES TWO RECHARGEABLE BATTERIES AND A SINGLE CELL BATTERY CHARGER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ORTHOPAK2 BONE GROWTH STIMULATOR SYSTEM AND IS INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLE PROGRESSIVE SIGNS OF HEALING.
-
-