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.
| Device | ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | EBI, LLC |
| Date Received | 2006-02-06 |
| Decision Date | 2006-07-27 |
| PMA | P850022 |
| Supplement | S016 |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EBI, LLC 399 Jefferson Road parsippany, NJ 07054 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P850022 | | Original Filing |
| S031 |
2022-10-28 |
30-day Notice |
| S030 |
2019-09-10 |
Real-time Process |
| S029 |
2018-03-01 |
30-day Notice |
| S028 |
2016-11-08 |
30-day Notice |
| S027 |
2015-12-17 |
30-day Notice |
| S026 |
2015-10-08 |
30-day Notice |
| S025 |
2015-08-10 |
30-day Notice |
| S024 |
2015-04-24 |
Real-time Process |
| S023 |
2014-08-04 |
30-day Notice |
| S022 |
2014-04-10 |
30-day Notice |
| S021 |
2014-02-24 |
30-day Notice |
| S020 |
2013-08-13 |
Special (immediate Track) |
| S019 | | |
| S018 |
2011-06-13 |
Real-time Process |
| S017 |
2009-09-16 |
Normal 180 Day Track |
| S016 |
2006-02-06 |
Normal 180 Day Track |
| S015 |
2003-09-30 |
Normal 180 Day Track |
| S014 |
2003-04-23 |
Special (immediate Track) |
| S013 |
2001-06-11 |
Normal 180 Day Track |
| S012 |
1999-07-09 |
Real-time Process |
| S011 |
1998-06-18 |
Real-time Process |
| S010 | | |
| S009 |
1997-03-13 |
Panel Track |
| S008 |
1992-10-05 |
Normal 180 Day Track |
| S007 |
1992-09-24 |
Normal 180 Day Track |
| S006 |
1989-08-25 |
Normal 180 Day Track |
| S005 |
1989-01-26 |
Normal 180 Day Track |
| S004 |
1987-08-04 |
Normal 180 Day Track |
| S003 |
1986-11-17 |
Special (immediate Track) |
| S002 | | |
| S001 |
1986-09-16 |
Special (immediate Track) |
NIH GUDID Devices