The following data is part of a premarket notification filed by Otis Biotech Co., Ltd. with the FDA for Prolixus Total Knee System.
| Device ID | K170534 |
| 510k Number | K170534 |
| Device Name: | PROLIXUS TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OTIS Biotech Co., Ltd. 15-118. MTV Buk-ro, 193beon-gil Building 14,2nd Floor, Siheung- Siheung-si, KR 15118 |
| Contact | Sanjay Lingot |
| Correspondent | Sanjay Lingot OTIS Biotech Co., Ltd. 15-118. MTV Buk-ro, 193beon-gil Building 14,2nd Floor, Siheung- Siheung-si, KR 15118 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-23 |
| Decision Date | 2017-11-09 |
| Summary: | summary |