| Primary Device ID | M572TPS030063N011 |
| NIH Device Record Key | 77d76f94-e84d-40af-b7b0-3b21a9a23f89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Identity Imprint Knee Replacement System |
| Version Model Number | TPS030063N01 |
| Catalog Number | TPS-030-063N |
| Company DUNS | 808821883 |
| Company Name | Conformis, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M572TPS030063N011 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-17 |
| Device Publish Date | 2021-06-09 |
| M572TPS301T07S011 | PS TIBIAL TRAY SIZE 7 |
| M572TPS301T06S011 | PS TIBIAL TRAY SIZE 6 |
| M572TPS301T06N011 | PS TIBIAL TRAY SIZE 6 NARROW |
| M572TPS301T05S011 | PS TIBIAL TRAY SIZE 5 |
| M572TPS301T05N011 | PS TIBIAL TRAY SIZE 5 NARROW |
| M572TPS301T04S011 | PS TIBIAL TRAY SIZE 4 |
| M572TPS301T04N011 | PS TIBIAL TRAY SIZE 4 NARROW |
| M572TPS301T03S011 | PS TIBIAL TRAY SIZE 3 |
| M572TPS301T03N011 | PS TIBIAL TRAY SIZE 3 NARROW |
| M572TPS301T02S011 | PS TIBIAL TRAY SIZE 2 |
| M572TPS301T02N011 | PS TIBIAL TRAY SIZE 2 NARROW |
| M572TPS301T01S011 | PS TIBIAL TRAY SIZE 1 |
| M572TPS101F07S011 | PS FEMORAL IMPLANT SIZE 7 LEFT or RIGHT |
| M572TPS101F06S011 | PS FEMORAL IMPLANT SIZE 6 LEFT or RIGHT |
| M572TPS101F06N011 | PS FEMORAL IMPLANT SIZE 6 NARROW LEFT or RIGHT |
| M572TPS101F05S011 | PS FEMORAL IMPLANT SIZE 5 LEFT or RIGHT |
| M572TPS101F05N011 | PS FEMORAL IMPLANT SIZE 5 NARROW LEFT or RIGHT |
| M572TPS101F04S011 | PS FEMORAL IMPLANT SIZE 4 LEFT or RIGHT |
| M572TPS101F04N011 | PS FEMORAL IMPLANT SIZE 4 Narrow LEFT or RIGHT |
| M572TPS101F03S011 | PS FEMORAL IMPLANT SIZE 3 LEFT or RIGHT |
| M572TPS101F03N011 | PS FEMORAL IMPLANT SIZE 3 Narrow LEFT or RIGHT |
| M572TPS101F02S011 | PS FEMORAL IMPLANT SIZE 2 LEFT or RIGHT |
| M572TPS101F02N011 | PS FEMORAL IMPLANT SIZE 2 Narrow LEFT or Right |
| M572TPS101F01S011 | PS FEMORAL IMPLANT SIZE 1 LEFT or Right |
| M572TCR301T07S011 | CR TIBIAL TRAY SIZE 7 |
| M572TCR301T06S011 | CR TIBIAL TRAY SIZE 6 |
| M572TCR301T06N01 | CR TIBIAL TRAY SIZE 6 NARROW |
| M572TCR301T05S011 | CR TIBIAL TRAY SIZE 5 |
| M572TCR301T05N011 | CR TIBIAL TRAY SIZE 5 NARROW |
| M572TCR301T04S011 | CR TIBIAL TRAY SIZE 4 |
| M572TCR301T04N011 | CR TIBIAL TRAY SIZE 4 NARROW |
| M572TCR301T03S011 | CR TIBIAL TRAY SIZE 3 |
| M572TCR301T03N011 | CR TIBIAL TRAY SIZE 3 NARROW |
| M572TCR301T02S011 | CR TIBIAL TRAY SIZE 2 |
| M572TCR301T02N011 | CR TIBIAL TRAY SIZE 2 NARROW |
| M572TCR301T01S011 | CR TIBIAL TRAY SIZE 1 |
| M572TCR101F07S011 | CR FEMORAL IMPLANT SIZE 7 LEFT or Right |
| M572TCR101F06S011 | CR FEMORAL IMPLANT SIZE 6 LEFT or Right |
| M572TCR101F06N011 | CR FEMORAL IMPLANT SIZE 6 Narrow LEFT or Right |
| M572TCR101F05S011 | IDENTITY IMPRINT CR FEMORAL IMPLANT SIZE 5 LEFT or Right |
| M572TCR101F05N011 | CR FEMORAL IMPLANT SIZE 5 Narrow LEFT or Right |
| M572TCR101F04S011 | CR FEMORAL IMPLANT SIZE 4 LEFT or RIGHT |
| M572TCR101F04N011 | CR FEMORAL IMPLANT SIZE 4 Narrow LEFT or Right |
| M572TCR101F03S011 | CR FEMORAL IMPLANT SIZE 3 LEFT or Right |
| M572TCR101F03N011 | CR FEMORAL IMPLANT SIZE 3 Narrow LEFT or Right |
| M572TCR101F02S011 | CR FEMORAL IMPLANT SIZE 2 LEFT or Left |
| M572TCR101F02N011 | CR FEMORAL IMPLANT SIZE 2 Narrow LEFT or RIGHT |
| M572TCR101F01S011 | CR FEMORAL IMPLANT SIZE 1 LEFT or RIGHT |
| M572TCR020163N011 | CR TIBIAL INSERT SIZE 3 NARROW 16MM LEFT AND RIGHT |
| M572TCR020162S011 | CR TIBIAL INSERT SIZE 2 16MM LEFT AND RIGHT |