Approval for use in the treatment of patients with painful degenerative or post-traumatic arthritis (hallux limitus or hallux rigidus) in the first metatarsophalangeal joint with or without the presence of mild hallux valgus.
| Device | CARTIVA SYNTHETIC CARTILAGE IMPLANT |
| Classification Name | Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant |
| Generic Name | Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant |
| Applicant | Cartiva, Inc |
| Date Received | 2015-05-01 |
| Decision Date | 2016-07-01 |
| Notice Date | 2016-07-08 |
| PMA | P150017 |
| Supplement | S |
| Product Code | PNW |
| Docket Number | 16M-1916 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cartiva, Inc 6120 Windward Parkway suite 220 alpharetta, GA 30005 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150017 | | Original Filing |
| S015 |
2021-06-30 |
Normal 180 Day Track No User Fee |
| S014 |
2019-10-30 |
30-day Notice |
| S013 | | |
| S012 |
2019-02-22 |
Special (immediate Track) |
| S011 | | |
| S010 | | |
| S009 |
2018-06-06 |
30-day Notice |
| S008 |
2018-06-04 |
30-day Notice |
| S007 |
2017-11-15 |
Normal 180 Day Track No User Fee |
| S006 |
2017-10-13 |
30-day Notice |
| S005 |
2017-01-31 |
Special (immediate Track) |
| S004 |
2016-12-06 |
30-day Notice |
| S003 |
2016-08-15 |
Real-time Process |
| S002 |
2016-08-01 |
Normal 180 Day Track No User Fee |
| S001 |
2016-08-01 |
30-day Notice |
NIH GUDID Devices