Itotal® CR Ipoly™ Insert Kit
Itotal CR?IPOLY?8MM Medial Insert Kit?left
21manufacturers in China registered for this device type
29catalogue numbers in this listing
40510(k) clearances naming this product code
19recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | ConforMIS, Inc., United States |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Remanufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K153721 |
| Record published | 2015-10-26 |
| Record revised | 2022-08-15 (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, serial number |
| Sizes | Height 6 to 16 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RCR010000B01 | 7mm thick + patient specific offset | In distribution |
| RCR010000G13 | Patient Specific | In distribution |
| RCR010000C13 | Patient Specific | In distribution |
| RCR010140002 | Height 14 mm | In distribution |
| RCR010100013 | Height 10 mm | In distribution |
| RCR010070003 | Height 7 mm | In distribution |
| RCR010000I13 | Patient Specific | In distribution |
| RCR010000A01 | 6mm thick + patient specific offset | In distribution |
| RCR010000J03 | 15mm thick + patient specific offset | In distribution |
| RCR010080002 | Height 8 mm | In distribution |
| RCR010000D01 | 9mm thick + patient specific offset | In distribution |
| RCR010000F02 | 11mm thick + patient specific offset | In distribution |
| RCR010100001 | Height 10 mm | In distribution |
| RCR010000E01 | 10mm thick + patient specific offset | In distribution |
| RCR010000E13 | Patient Specific | In distribution |
| RCR010120002 | Height 12 mm | In distribution |
| RCR010000J13 | Patient Specific | In distribution |
| RCR010000C02 | 8mm thick + patient specific offset | In distribution |
| RCR010000K13 | Patient Specific | In distribution |
| RCR010000J02 | 15mm thick + patient specific offset | In distribution |
| RCR010000I01 | 14mm thick + patient specific offset | In distribution |
| RCR010000B13 | Patient Specific | In distribution |
| RCR010000D13 | Patient Specific | In distribution |
| RCR010000H13 | Patient Specific | In distribution |
| RCR010000D02 | 9mm thick + patient specific offset | In distribution |
| RCR010000G03 | 12mm thick + patient specific offset | In distribution |
| RCR010060002 | Height 6 mm | In distribution |
| RCR010000H01 | 13mm thick + patient specific offset | In distribution |
| RCR010160002 | Height 16 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230846 | 2023-07-17 |
| K231233 | 2023-05-26 |
| K230844 | 2023-04-27 |
| K221404 | 2022-07-26 |
| K221059 | 2022-05-10 |
| K213389 | 2021-11-10 |
| K212411 | 2021-09-23 |
| K210809 | 2021-05-12 |
| K210191 | 2021-05-06 |
| K210252 | 2021-02-17 |
| K203447 | 2020-12-22 |
| K201023 | 2020-06-16 |
| K193105 | 2020-03-13 |
| K190562 | 2019-08-08 |
| K180906 | 2018-05-16 |
| K161668 | 2016-07-15 |
| K161366 | 2016-06-14 |
| K153721 | 2016-03-25 |
| K160025 | 2016-03-07 |
| K153217 | 2016-01-07 |
| K152704 | 2015-10-21 |
| K142404 | 2014-12-11 |
| K142161 | 2014-11-14 |
| K140833 | 2014-06-30 |
| K140423 | 2014-05-27 |
| K133560 | 2014-03-28 |
| K133256 | 2014-01-09 |
| K131467 | 2013-07-18 |
| K131019 | 2013-05-24 |
| K122870 | 2013-01-14 |
| K122991 | 2012-12-20 |
| K122033 | 2012-09-27 |
| K120316 | 2012-04-19 |
| K113378 | 2012-02-15 |
| K120068 | 2012-02-03 |
| K112780 | 2011-12-15 |
| K103117 | 2011-01-07 |
| K094050 | 2010-09-16 |
| K080936 | 2008-05-12 |
| K052687 | 2006-08-31 |
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
12 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 |
|---|---|---|---|---|---|
| 2024-03-11 | Class II | Process design | Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack. | 3 units | |
| 2022-02-22 | Class II | Nonconforming Material/Component | Incorrect tibial base plate implant packaged in kit | 1 unit | |
| 2020-07-20 | Class II | Packaging process control | Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920 | 1 kit | 2021-06-21 |
| 2020-02-03 | Class II | Mixed-up of materials/components | A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts. | 4 | 2020-12-02 |
| 2020-02-03 | Class II | Mixed-up of materials/components | A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts. | 2 | 2020-12-02 |
| 2019-10-25 | Class II | Under Investigation by firm | Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant. | 1 unit | 2020-05-20 |
| 2019-01-04 | Class II | Employee error | The labeling of the boxes and sterile pouches did not match the contents. | 2 | 2020-06-29 |
| 2018-12-03 | Class II | Labeling mix-ups | The kits were prepared with incorrect patient ID labels and may contain incorrect components. | 2 | 2020-06-26 |
| 2017-07-24 | Class II | Employee error | Implant kit mislabeled | 2 units | 2019-02-01 |
| 2016-10-31 | Class II | Software Design Change | iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm). | 1 unit | 2017-01-11 |
| 2016-10-18 | Class II | Labeling Change Control | Mislabeled: incorrect serial number on the F4 A/P cut guide iJig. | 2 units | 2016-12-07 |
| 2012-07-17 | Class II | Device Design | Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique | 1427 units | 2013-02-27 |
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.