The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for World Knee Total Knee Systems.
| Device ID | K190577 |
| 510k Number | K190577 |
| Device Name: | World Knee Total Knee Systems |
| 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 | 2019-03-06 |
| Decision Date | 2019-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348215032166 | K190577 | 000 |
| 09348215062026 | K190577 | 000 |
| 09348215062033 | K190577 | 000 |
| 09348215062040 | K190577 | 000 |
| 09348215062057 | K190577 | 000 |
| 09348215062064 | K190577 | 000 |
| 09348215062071 | K190577 | 000 |
| 09348215062088 | K190577 | 000 |
| 09348215062095 | K190577 | 000 |
| 09348215062101 | K190577 | 000 |
| 09348215032173 | K190577 | 000 |
| 09348215032098 | K190577 | 000 |
| 09348215032104 | K190577 | 000 |
| 09348215032111 | K190577 | 000 |
| 09348215032128 | K190577 | 000 |
| 09348215032135 | K190577 | 000 |
| 09348215032142 | K190577 | 000 |
| 09348215032159 | K190577 | 000 |
| 09348215062019 | K190577 | 000 |