Itotal® Hip Replacement System
HIP-Ipoly XE-Liner-GRP D (54-57) 36MM STD (PLN)
8manufacturers in China registered for this device type
131catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 4 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 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | 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 |
| Shenzhen Fox Hunting E-commerce Co., Ltd. | Shenzhen | Guangdong | Exporter | 7 |
Record
| Listed by | ConforMIS, Inc., United States |
|---|---|
| FDA product code | OQG |
| Device type | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Remanufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K162719 |
| Record published | 2018-08-29 |
| Record revised | 2024-10-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | expiry date, serial number |
| Distribution end date | 2022-08-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HAR000S25301 | 2-53mm | In distribution |
| HDL060D32L01 | Group D 40mm LIP | In distribution |
| HDL060F20S01 | Group F 36mm +0 STD | In distribution |
| HAH04040SH01 | 40mm SH | In distribution |
| HAR000S14601 | 1-46mm | In distribution |
| HDL060E20S01 | Group E 36mm +0 STD | In distribution |
| HAH01036MD01 | 36mm MD | In distribution |
| HDL060D22S01 | Group D 36mm STD | In distribution |
| HAR000S26101 | 2-61mm | In distribution |
| HDL060F22F01 | Group F 36mm FC | In distribution |
| HAR000S15801 | 1-58mm | In distribution |
| HAR000S16301 | 1-63mm | In distribution |
| HDL060F32F01 | Group F 40mm FC | In distribution |
| HAH04036LG01 | 36mm LG | In distribution |
| HAR000S14701 | 1-47mm | In distribution |
| HAR000S25501 | 2-55mm | In distribution |
| HAR000S24901 | 2-49mm | In distribution |
| HDL060E22S01 | Group E 36mm STD | In distribution |
| HAR000S25401 | 2-54mm | In distribution |
| HAR000S25801 | 2-58mm | In distribution |
| HDL060E32S01 | Group E 40mm STD | In distribution |
| HDL060E32L01 | Group E 40mm LIP | In distribution |
| HAR000S26401 | 2-64mm | In distribution |
| HDL060C22L01 | Group C 36mm LIP | In distribution |
| HDL060B12F01 | Group B 32mm +2 FC | In distribution |
| HAR000S25901 | 2-59mm | In distribution |
| HDL060C24S01 | Group C 36mm LAT STD | In distribution |
| HAH04036MD01 | 36mm MD | In distribution |
| HDL060F20L01 | Group F 36mm +0 LIP | In distribution |
| HDL060C22F01 | Group C 36mm +2 FC | In distribution |
| HDL060C22S01 | Group C 36mm STD | In distribution |
| HDL060C10S01 | Group C 28mm +0 STD | In distribution |
| HAH04036XL01 | 36mm XL | In distribution |
| HDL060F30S01 | Group F 40mm +0 STD | In distribution |
| HAR000S16401 | 1-64mm | In distribution |
| HAR000S24501 | 2-45mm | In distribution |
| HAR000S24701 | 2-47mm | In distribution |
| HAR000S16201 | 1-62mm | In distribution |
| HAA030062501 | 6.5mm X 25mm | In distribution |
| HDL060F34S01 | Group F 40mm STD | In distribution |
| HDL060F20F01 | Group F 36mm +0 FC | In distribution |
| HAH04032XL01 | 32mm XL | In distribution |
| HAA030063001 | 6.5mm X 30mm | In distribution |
| HDL060D20L01 | Group D 36mm +0 LIP | In distribution |
| HAR000S14901 | 1-49mm | In distribution |
| HAR000S15301 | 1-53mm | In distribution |
| HDL060F24S01 | Group F 36mm LAT STD | In distribution |
| HAA030061501 | 6.5mm X 15mm | In distribution |
| HDL060E30F01 | Group E 40mm +0 FC | In distribution |
| HAR000S15001 | 1-50mm | In distribution |
| HAR000S15501 | 1-55mm | In distribution |
| HAH04028MD01 | 28mm MD | In distribution |
| HAR000S25001 | 2-50mm | In distribution |
| HAR000S15101 | 1-51mm | In distribution |
| HAR000S26001 | 2-60mm | In distribution |
| HAH04028LG01 | 28mm LG | In distribution |
| HAR000S15401 | 1-54mm | In distribution |
| HDL060E22L01 | Group E 36mm LIP | In distribution |
| HAA030062001 | 6.5mm X 20mm | In distribution |
| HAR000S15701 | 1-57mm | In distribution |
| HDL060E20F01 | Group E 36mm +0 FC | In distribution |
| HDL060F30L01 | Group F 40mm +0 LIP | In distribution |
| HAR000S16501 | 1-65mm | In distribution |
| HBS033000001 | Patient Specific | In distribution |
| HAR000S26201 | 2-62mm | In distribution |
| HDL060E34S01 | Group E 40mm LAT STD | In distribution |
| HDL060F30F01 | Group F 40mm +0 FC | In distribution |
| HAH01028MD01 | 28mm MD | In distribution |
| HDL060E24S01 | Group E 36mm LAT STD | In distribution |
| HDL060E32F01 | Group E 40mm FC | In distribution |
| HDL060F32S01 | Group F 40mm STD | In distribution |
| HAR000S16001 | 1-60mm | In distribution |
| HAR000S25701 | 2-57mm | In distribution |
| HAH01036XL01 | 36mm XL | In distribution |
| HAH04032SH01 | 32mm SH | In distribution |
| HAH04040MD01 | 40mm MD | In distribution |
| HDL060B00S01 | Group B 28mm +0 STD | In distribution |
| HDL060D20F01 | Group D 36mm +0 FC | In distribution |
| HAA030064001 | 6.5mm X 40mm | In distribution |
| HAH01028SH01 | 28mm SH | In distribution |
| HDL060B14S01 | Group B 32mm +4 STD | In distribution |
| HAR000S14501 | 1-45mm | In distribution |
| HAH01036SH01 | 36mm SH | In distribution |
| HDL060C10L01 | Group C 32mm +0 LIP | In distribution |
| HAR000S15901 | 1-59mm | In distribution |
| HAH01032LG01 | 32 LG mm | In distribution |
| HDL060E22F01 | Group E 36mm FC | In distribution |
| HAR000S25101 | 2-51mm | In distribution |
| HAR000S26501 | 2-65mm | In distribution |
| HAH04040XL01 | 40mm XL | In distribution |
| HAH01028LG01 | 28mm LG | In distribution |
| HAR000S16101 | 1-61mm | In distribution |
| HDL060C10F01 | Group C 32mm +0 FC | In distribution |
| HDL060D24S01 | Grpup D 36mm LAT STD | In distribution |
| HDL060D32S01 | Group D 40mm STD | In distribution |
| HDL060B12S01 | Group B 32mm +2 STD | In distribution |
| HDL060D34S01 | Group D 40mm LAT STD | In distribution |
| HDL060F32L01 | Group F 40mm LIP | In distribution |
| HAH01032MD01 | 32mm MD | In distribution |
| HAH04036SH01 | 36mm SH | In distribution |
| HDL060D22L01 | Grpup D 36mm LIP | In distribution |
| HDL060D20S01 | Group D 36mm +0 STD | In distribution |
| HAH04032MD01 | 32mm MD | In distribution |
| HAH04032LG01 | 32mm LG | In distribution |
| HDL060F22L01 | Group F 36mm LIP | In distribution |
| HAR000S26301 | 2-63mm | In distribution |
| HAA030064501 | 6.5mm X 45mm | In distribution |
| HDL060E30L01 | Group E 40mm +0 LIP | In distribution |
| HDL060F22S01 | Group F 36mm STD | In distribution |
| HAR000S14801 | 1-48mm | In distribution |
| HDL060D22F01 | Group D 36mm FC | In distribution |
| HAR000S25201 | 2-52mm | In distribution |
| HAH01028XL01 | 28mm XL | In distribution |
| HAH01036LG01 | 36 LG mm | In distribution |
| HAH01032SH01 | 32mm SH | In distribution |
| HAA030063501 | 6.5mm X 35mm | In distribution |
| HDL060B00F01 | Group B 28mm +0 FC | In distribution |
| HAH01032XL01 | 32mm XL | In distribution |
| HDL060B00L01 | Group B 28mm +0 LIP | In distribution |
| HAR000S24801 | 2-48mm | In distribution |
| HAR000S25601 | 2-56mm | In distribution |
| HAR000S15601 | 1-56 mm | In distribution |
| HAR000S24601 | 2-46mm | In distribution |
| HDL060E20L01 | Group E 36mm +0 LIP | In distribution |
| HAR000S15201 | 1-52mm | In distribution |
| HDL060B12L01 | Group B 32mm +2 LIP | In distribution |
| HAH04040LG01 | 40mm LG | In distribution |
| HAA030065001 | 6.5mm X 50mm | In distribution |
| HDL060E30S01 | Group E 40mm +0 STD | In distribution |
| HCC032000001 | Patient Specific | Withdrawn |
| HAA050D00101 | Patient Specific | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CS2 Acet. Cup Sys. – VitalitE | Shalby Advanced Technologies, Inc. | 169 |
| CS2 Acet. Cup Sys. – VitalitE | Consensus Orthopedics, Inc. | 124 |
| DJO Surgical | Encore Medical, L.P. | 99 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 68 |
| G7 | Biomet Orthopedics | 54 |
| Vitelene® | Aesculap AG | 52 |
| Conformis Hip System | ConforMIS, Inc. | 51 |
| Onvoy | Globus Medical, Inc. | 48 |
| Ringloc HIP System | Biomet Orthopedics | 35 |
| Novosource Total Hip System | Novosource, LLC | 33 |
| Prime | Microport Orthopedics Inc. | 32 |
| NovoHip Total Hip System | Novosource, LLC | 28 |
Showing 12 of 100. All products under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ConforMIS, Inc. | UDI-DI | 2025-03-25 | Class II | Labeling Change Control | The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner. | 16 | |
| ConforMIS, Inc. | UDI-DI | 2023-06-16 | Class II | Error in labeling | 30mm screws were labeled as 25mm screws. | 25 units | |
| ConforMIS, Inc. | 510(k) number | 2019-08-22 | Class II | Under Investigation by firm | Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other’s packaging. | 1 | 2020-07-08 |
| ConforMIS, Inc. | 510(k) number | 2019-08-22 | Class II | Under Investigation by firm | Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other’s packaging. | 1 | 2020-07-08 |
| ConforMIS, Inc. | 510(k) number | 2019-03-29 | Class II | Device Design | Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants. | 128 | 2020-04-28 |
| ConforMIS, Inc. | 510(k) number | 2018-10-16 | Class II | Under Investigation by firm | The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm. | 1 | 2020-06-29 |
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.