Itotal® CR Ipoly™ Insert Kit
59 catalogue numbers from RCR010000A02, listed by ConforMIS, Inc., United States, under Knee Arthroplasty Implantation System. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
59catalogue 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 |
| 510(k) | K120316 |
| Record published | 2015-10-26 |
| Record revised | 2022-08-17 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | expiry date, manufacturing date, serial number |
| Sizes | Height 6 to 16 mm; length 9 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RCR010000A02 | 6mm thick + patient specific offset | In distribution |
| RCR010130002 | Height 13 mm | In distribution |
| RCR010000B02 | 7mm thick + patient specific offset | In distribution |
| RCR010130003 | Height 13 mm | In distribution |
| RCR010000H03 | 13mm thick + patient specific offset | In distribution |
| RCR010100002 | Height 10 mm | In distribution |
| RCR010160001 | Height 16 mm | In distribution |
| RCR010160013 | Height 16 mm | In distribution |
| RCR010060001 | Height 6 mm | In distribution |
| RCR010140013 | Height 14 mm | In distribution |
| RCR010000F01 | 11mm thick + patient specific offset | In distribution |
| RCR010000G01 | 12mm thick + patient specific offset | In distribution |
| RCR010070001 | Height 7 mm | In distribution |
| RCR010090013 | Height 9 mm | In distribution |
| RCR010140001 | Height 14 mm | In distribution |
| RCR010080001 | Height 8 mm | In distribution |
| RCR010070013 | Height 7 mm | In distribution |
| RCR010150013 | Height 15 mm | In distribution |
| RCR010150003 | Height 15 mm | In distribution |
| RCR010000C01 | 8mm thick + patient specific offset | In distribution |
| RCR010090003 | Height 9 mm | In distribution |
| RCR010150002 | Height 15 mm | In distribution |
| RCR010060013 | Height 6 mm | In distribution |
| RCR010000A03 | 6mm thick + patient specific offset | In distribution |
| RCR010000H02 | 13mm thick + patient specific offset | In distribution |
| RCR010110001 | Height 11 mm | In distribution |
| RCR010130001 | Height 13 mm | In distribution |
| RCR010000A13 | Patient Specific | In distribution |
| RCR010150001 | Height 15 mm | In distribution |
| RCR010000I03 | 14mm thick + patient specific offset | In distribution |
| RCR010120001 | Height 12 mm | In distribution |
| RCR010110002 | Height 11 mm | In distribution |
| RCR010100003 | Height 10 mm | In distribution |
| RCR010110003 | Height 11 mm | In distribution |
| RCR010160003 | Height 16 mm | In distribution |
| RCR010000C03 | 8mm thick + patient specific offset | In distribution |
| RCR010120013 | Height 12 mm | In distribution |
| RCR010000J01 | 15mm thick + patient specific offset | In distribution |
| RCR010000E02 | 10mm thick + patient specific offset | In distribution |
| RCR010000K01 | 16mm thick + patient specific offset | In distribution |
| RCR010000F03 | 11mm thick + patient specific offset | In distribution |
| RCR010090001 | Length 9 mm | In distribution |
| RCR010120003 | Height 12 mm | In distribution |
| RCR010000F13 | Patient Specific | In distribution |
| RCR010000I02 | 14mm thick + patient specific offset | In distribution |
| RCR010140003 | Height 14 mm | In distribution |
| RCR010060003 | Height 6 mm | In distribution |
| RCR010000G02 | 12mm thick + patient specific offset | In distribution |
| RCR010080013 | Height 8 mm | In distribution |
| RCR010110013 | Height 11 mm | In distribution |
| RCR010000E03 | 10mm thick + patient specific offset | In distribution |
| RCR010130013 | Height 13 mm | In distribution |
| RCR010070002 | Height 7 mm | In distribution |
| RCR010000K03 | 16mm thick + patient specific offset | In distribution |
| RCR010000D03 | 9mm thick + patient specific offset | In distribution |
| RCR010000B03 | 7mm thick + patient specific offset | In distribution |
| RCR010090002 | Height 9 mm | In distribution |
| RCR010000K02 | 16mm thick + patient specific offset | In distribution |
| RCR010080003 | Height 8 mm | 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 |
| 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® Identity Cruciate Retaining Knee Replacement System | ConforMIS, Inc. | 27 |
| 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 Naming This Product
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ConforMIS, Inc. | 510(k) number | 2016-01-28 | Class II | Packaging process control | Incorrect femoral component distributed | 1 unit | 2016-03-09 |
| ConforMIS, Inc. | 510(k) number | 2015-08-31 | Class II | Process design | May contain small amounts of ethylene glycol residue | 68 units | 2016-03-02 |
| ConforMIS, Inc. | 510(k) number | 2015-08-31 | Class II | Process design | May contain small amounts of ethylene glycol residue | 3 units | 2016-03-02 |
| ConforMIS, Inc. | 510(k) number | 2015-08-31 | Class II | Process design | May contain small amounts of ethylene glycol residue | 313 units | 2016-03-02 |
| ConforMIS, Inc. | 510(k) number | 2015-08-31 | Class II | Process design | May contain small amounts of ethylene glycol residue | 348 units | 2016-03-02 |
| ConforMIS, Inc. | 510(k) number | 2015-08-31 | Class II | Process design | May contain small amounts of ethylene glycol residue | 110 units | 2016-03-02 |
| ConforMIS, Inc. | 510(k) number | 2014-11-19 | Class II | Labeling mix-ups | Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting | 1 unit | 2015-10-08 |
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.