Identity Imprint Porous CR
Identity Imprint Porous CR is a modular knee replacement system with standard implant sizes selected using patient CT images. Porous titanium scaffolds on the bone-contacting sides of its…
Identity Imprint Porous CR is a modular knee replacement system with standard implant sizes selected using patient CT images. Porous titanium scaffolds on the bone-contacting sides of its components provide an interface for biological fixation.
The femoral component is cobalt-chromium-molybdenum with a commercially pure titanium scaffold. The tibial tray uses titanium alloy with a porous titanium scaffold, paired with a vitamin-E-enriched highly cross-linked polyethylene insert.
Listed Item
Identity Imprint Porous CR Femoral Implant Size 4N Left OR Right
Fixation and Instruments
Porous femoral, tibial and patellar components are designed for cementless fixation but may also be cemented. Patient-specific nylon cutting and positioning guides are supplied sterile for single use, with separate reusable instruments also available.
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | ConforMIS, Inc., United States |
|---|---|
| FDA product code | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| Establishment | Remanufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K223316 |
| Record published | 2023-09-08 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TCR-302-T03S-01 | Size 3 | In distribution |
| TCR-302-T02N-01 | Size 2 Narrow | In distribution |
| TCR-102-F04N-01 | Size 4 Narrow | In distribution |
| TCR-302-T03N-01 | Size 3 Narrow | In distribution |
| TCR-102-F06N-01 | size 6 narrow | In distribution |
| TCR-302-T02S-01 | Size 2 | In distribution |
| POV-012-3809-01 | 38MM X 9MM | In distribution |
| POV-012-3208-01 | 32MM X 8MM | In distribution |
| TCR-302-T04N-01 | Size 4 Narrow | In distribution |
| TCR-102-F01S-01 | Size 1 | In distribution |
| TCR-302-T06S-01 | Size 6 | In distribution |
| TCR-102-F02S-01 | Size 2 | In distribution |
| TCR-302-T01S-01 | size 1 | In distribution |
| TCR-102-F03S-01 | size 3 | In distribution |
| TCR-102-F07S-01 | Size 7 | In distribution |
| TCR-302-T04S-01 | Size 4 | In distribution |
| TCR-302-T07S-01 | Size 7 | In distribution |
| POV-012-4110-01 | 41MM X 10MM | In distribution |
| TCR-102-F02N-01 | Size 2 Narrow | In distribution |
| TCR-102-F05S-01 | size 5 | In distribution |
| TCR-302-T05S-01 | Size 5 | In distribution |
| TCR-102-F04S-01 | size 4 | In distribution |
| TCR-102-F05N-01 | Size 5 Narrow | In distribution |
| TCR-302-T05N-01 | Size 5 Narrow | In distribution |
| TCR-102-F06S-01 | size 6 | In distribution |
| POV-012-3509-01 | 35MM X 9MM | In distribution |
| POV-012-4411-01 | 44MM X 11MM | In distribution |
| TCR-302-T06N-01 | Size 6 Narrow | In distribution |
| TCR-102-F03N-01 | Size 3 Narrow | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| Attune | Depuy (Ireland) | 234 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232426 | 2023-09-08 |
| K223316 | 2023-07-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.