The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Active-x Total Knee System.
| Device ID | K160159 |
| 510k Number | K160159 |
| Device Name: | Active-X Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove, AU 2066 |
| Contact | Declan Brazil |
| Correspondent | Declan Brazil Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove, AU 2066 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348215011253 | K160159 | 000 |
| 09348215010874 | K160159 | 000 |
| 09348215011321 | K160159 | 000 |
| 09348215011314 | K160159 | 000 |
| 09348215011307 | K160159 | 000 |
| 09348215011291 | K160159 | 000 |
| 09348215011284 | K160159 | 000 |
| 09348215011277 | K160159 | 000 |
| 09348215011260 | K160159 | 000 |
| 09348215018139 | K160159 | 000 |
| 09348215018122 | K160159 | 000 |
| 09348215018115 | K160159 | 000 |
| 09348215018108 | K160159 | 000 |
| 09348215018092 | K160159 | 000 |
| 09348215013080 | K160159 | 000 |
| 09348215013073 | K160159 | 000 |
| 09348215013066 | K160159 | 000 |
| 09348215013059 | K160159 | 000 |
| 09348215010881 | K160159 | 000 |
| 09348215010898 | K160159 | 000 |
| 09348215011246 | K160159 | 000 |
| 09348215011239 | K160159 | 000 |
| 09348215011222 | K160159 | 000 |
| 09348215011215 | K160159 | 000 |
| 09348215011208 | K160159 | 000 |
| 09348215011192 | K160159 | 000 |
| 09348215011185 | K160159 | 000 |
| 09348215011178 | K160159 | 000 |
| 09348215011161 | K160159 | 000 |
| 09348215011154 | K160159 | 000 |
| 09348215010966 | K160159 | 000 |
| 09348215010959 | K160159 | 000 |
| 09348215010942 | K160159 | 000 |
| 09348215010935 | K160159 | 000 |
| 09348215010928 | K160159 | 000 |
| 09348215010911 | K160159 | 000 |
| 09348215010904 | K160159 | 000 |
| 09348215013042 | K160159 | 000 |