Itotal® Identity Cruciate Retaining Knee Replacement System
Itotal Identity 12X20MM Tibial Stem Extension (Titanium, Cemented)
8manufacturers in China registered for this device type
57catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| 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 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | ConforMIS, Inc., United States |
|---|---|
| FDA product code | OIY |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Remanufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2019-10-01 |
| Record revised | 2022-08-17 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Sizes | Height 6 to 14 mm; length 20 to 40 mm |
| Distribution end date | 2022-08-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TCR020000E01 | In distribution | |
| TCR020000G01 | In distribution | |
| TCR010000D01 | In distribution | |
| STM301122001 | Length 20 mm | In distribution |
| TCR020000B01 | In distribution | |
| TCR010120001 | Height 12 mm | In distribution |
| TCR010080C01 | Height 8 mm | In distribution |
| TCR010140J01 | Height 14 mm | In distribution |
| TCR020140001 | Height 14 mm | In distribution |
| TCR020080C01 | Height 8 mm | In distribution |
| TCR010090D01 | Height 9 mm | In distribution |
| TCR020000C01 | In distribution | |
| TCR010000C01 | In distribution | |
| TCR020060A01 | Height 6 mm | In distribution |
| TCR010000F01 | In distribution | |
| TCR101111201 | In distribution | |
| TCR010000E01 | In distribution | |
| TCR010090001 | Height 9 mm | In distribution |
| TCR010000G01 | In distribution | |
| TCR010070B01 | Height 7 mm | In distribution |
| TCR020000D01 | In distribution | |
| TCR010060A01 | Height 6 mm | In distribution |
| TCR020070001 | Height 7 mm | In distribution |
| TCR010130001 | Height 13 mm | In distribution |
| TCR020000F01 | In distribution | |
| TCR020130001 | Height 13 mm | In distribution |
| TCR020090001 | Height 9 mm | In distribution |
| TCR020130H01 | Height 13 mm | In distribution |
| TCR020090D01 | Height 9 mm | In distribution |
| TCR020000A01 | In distribution | |
| TCR020120G01 | Height 12 mm | In distribution |
| TCR020070B01 | Height 7 mm | In distribution |
| TCR010000B01 | In distribution | |
| TCR020140J01 | Height 14 mm | In distribution |
| TCR020080001 | Height 8 mm | In distribution |
| TCR020060001 | Height 6 mm | In distribution |
| TCR010100E01 | Height 10 mm | In distribution |
| TCR010100001 | Height 10 mm | In distribution |
| TCR000D00101 | In distribution | |
| TCR010080001 | Height 8 mm | In distribution |
| TCR020000H01 | In distribution | |
| TCR020120001 | Height 12 mm | In distribution |
| TCR010000H01 | In distribution | |
| TCR020100001 | Height 10 mm | In distribution |
| TCR010140001 | Height 14 mm | In distribution |
| TCR010070001 | Height 7 mm | In distribution |
| TCR010000A01 | In distribution | |
| TCR010130H01 | Height 13 mm | In distribution |
| TCR010120G01 | Height 12 mm | In distribution |
| TCR020110F01 | Height 11 mm | In distribution |
| STM301124001 | Length 40 mm | In distribution |
| TCR010060001 | Height 6 mm | In distribution |
| TCR010000J01 | In distribution | |
| TCR020100E01 | Height 10 mm | In distribution |
| TCR010110001 | Height 11 mm | In distribution |
| TCR020000J01 | In distribution | |
| TCR000SPEC01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Persona® | Zimmer, Inc. | 552 |
| DJO Surgical | Encore Medical, L.P. | 415 |
| Genflex2 Total Knee System | Globus Medical, Inc. | 389 |
| Persona® Vivacit-E® | Zimmer, Inc. | 332 |
| Truliant, Activit-E | Exactech, Inc. | 272 |
| TriVerse Meniscal Insert PS | Signature Orthopaedics PTY Limited | 220 |
| U2™ Knee | United Orthopedic Corp. | 195 |
| BKS E-Vitalize | Ortho Development Corp. | 193 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 169 |
| Attune | Depuy (Ireland) | 161 |
| Vanguard Complete Knee System | Biomet Orthopedics | 153 |
| EXp Tibial Inserts and Patellar Components | Globus Medical, Inc. | 144 |
Showing 12 of 102. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-11-14 | Class II | Process control | Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure. | 70 |
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.