Itotal® Identity Cruciate Retaining Knee Replacement System
Itotal Identity CR Tibial Insert, NO Trial, Ipoly, Single, 17MM, Left & Right
2manufacturers in China registered for this device type
27catalogue numbers in this listing
1510(k) clearance
3recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a 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 |
Record
| Listed by | ConforMIS, Inc., United States |
|---|---|
| FDA product code | OOG |
| Device type | Knee Arthroplasty Implantation System |
| 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 | 2019-12-11 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Sizes | Height 11 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RCR010170M11 | In distribution | |
| RCR010130H01 | In distribution | |
| RCR010120G01 | In distribution | |
| RCR010150K11 | In distribution | |
| RCR010170014 | In distribution | |
| RCR010170004 | In distribution | |
| RCR010140J01 | In distribution | |
| RCR010130014 | In distribution | |
| RCR010150004 | In distribution | |
| RCR010160L11 | In distribution | |
| RCR010120004 | In distribution | |
| RCR010160014 | In distribution | |
| RCR010180004 | In distribution | |
| RCR010170M01 | In distribution | |
| RCR010160004 | In distribution | |
| RCR010160L01 | In distribution | |
| RCR010130004 | In distribution | |
| RCR010140J11 | In distribution | |
| TCR020110001 | Height 11 mm | In distribution |
| RCR010140014 | In distribution | |
| RCR010140004 | In distribution | |
| RCR010130H11 | In distribution | |
| RCR010120014 | In distribution | |
| RCR010150K01 | In distribution | |
| RCR010150014 | In distribution | |
| RCR010120G11 | In distribution | |
| TCR301111301 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 1,463 |
| PointCloud Knee Instruments | Unik Orthopedics, Inc | 202 |
| iTotal Identity CR | ConforMIS, Inc. | 138 |
| My Knee Femoral Cutting Blocks | Medacta International SA | 60 |
| iTotal® CR iPoly™ Insert Kit | ConforMIS, Inc. | 59 |
| My Knee Tibial Cutting Blocks | Medacta International SA | 48 |
| My Knee Femoral Cutting Blocks MIS | Medacta International SA | 42 |
| My Knee Tibial Cutting Blocks MIS | Medacta International SA | 36 |
| iTotal® CR iPoly® XE Insert Kit | ConforMIS, Inc. | 16 |
| Zimmer Patient Specific Instruments | Materialise NV | 12 |
| iTotal Identity CR Knee Replacement System | ConforMIS, Inc. | 12 |
| iTotal® PS iPoly® XE Insert Kit | ConforMIS, Inc. | 11 |
Showing 12 of 95. All products under Knee Arthroplasty Implantation System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203421 | 2021-04-19 |
Recalls
3 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2015-08-31 | Class II | Process design | May contain small amounts of ethylene glycol residue | 7 units | 2016-03-02 |
| 2015-08-31 | Class II | Process design | May contain small amounts of ethylene glycol residue | 71 units | 2016-03-02 |
| 2015-08-31 | Class II | Process design | May contain small amounts of ethylene glycol residue | 6 units | 2016-03-02 |
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.