DJO Surgical
ACETABULAR LINERS Liner / Non-Hooded - Neutral, MP10, HXe-plus
8manufacturers in China registered for this device type
99catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Encore Medical, L.P., 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 | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K190057 |
| Record published | 2019-09-09 |
| Record revised | 2019-07-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 941-01-36H | In distribution | |
| 940-01-62I | In distribution | |
| 944-01-44J | In distribution | |
| 940-02-60I | In distribution | |
| 943-01-36J | In distribution | |
| 931-44-760 | In distribution | |
| 943-01-28C | In distribution | |
| 940-01-46C | In distribution | |
| 931-28-746 | In distribution | |
| 932-28-246 | In distribution | |
| 943-01-44I | In distribution | |
| 941-01-32F | In distribution | |
| 942-01-36J | In distribution | |
| 943-01-32H | In distribution | |
| 941-01-36G | In distribution | |
| 943-01-40F | In distribution | |
| 941-01-36D | In distribution | |
| 942-01-28A | In distribution | |
| 943-01-28A | In distribution | |
| 943-01-32E | In distribution | |
| 941-01-36K | In distribution | |
| 942-01-36H | In distribution | |
| 943-01-32G | In distribution | |
| 941-01-44K | In distribution | |
| 940-02-52F | In distribution | |
| 931-28-744 | In distribution | |
| 942-01-36D | In distribution | |
| 943-01-28B | In distribution | |
| 943-01-40K | In distribution | |
| 932-28-742 | In distribution | |
| 942-01-32C | In distribution | |
| 942-01-32H | In distribution | |
| 942-01-36F | In distribution | |
| 941-01-36J | In distribution | |
| 944-01-44I | In distribution | |
| 940-02-44B | In distribution | |
| 944-01-40G | In distribution | |
| 932-40-754 | In distribution | |
| 941-01-32H | In distribution | |
| 940-02-66J | In distribution | |
| 942-01-40K | In distribution | |
| 931-28-742 | In distribution | |
| 943-01-36D | In distribution | |
| 931-32-746 | In distribution | |
| 943-01-40I | In distribution | |
| 944-01-32C | In distribution | |
| 932-36-754 | In distribution | |
| 943-01-44H | In distribution | |
| 944-01-36G | In distribution | |
| 940-02-56H | In distribution | |
| 942-01-36K | In distribution | |
| 941-01-40J | In distribution | |
| 940-03-50E | In distribution | |
| 940-02-58H | In distribution | |
| 942-01-44J | In distribution | |
| 940-00-030 | In distribution | |
| 942-01-32B | In distribution | |
| 940-03-46C | In distribution | |
| 943-01-36F | In distribution | |
| 940-02-70K | In distribution | |
| 944-01-28C | In distribution | |
| 942-01-40H | In distribution | |
| 942-01-40I | In distribution | |
| 940-01-44B | In distribution | |
| 932-32-748 | In distribution | |
| 940-02-64J | In distribution | |
| 932-36-750 | In distribution | |
| 941-01-28C | In distribution | |
| 944-01-36E | In distribution | |
| 940-01-54G | In distribution | |
| 944-01-44H | In distribution | |
| 941-01-44H | In distribution | |
| 940-03-64J | In distribution | |
| 940-01-70K | In distribution | |
| 944-01-36J | In distribution | |
| 942-01-44H | In distribution | |
| 943-01-32F | In distribution | |
| 941-01-36I | In distribution | |
| 942-01-32E | In distribution | |
| 944-01-32D | In distribution | |
| 940-02-62I | In distribution | |
| 943-01-36I | In distribution | |
| 941-01-32E | In distribution | |
| 944-01-40J | In distribution | |
| 940-00-025 | In distribution | |
| 940-01-58H | In distribution | |
| 944-01-40H | In distribution | |
| 943-01-40J | In distribution | |
| 932-28-744 | In distribution | |
| 941-01-32D | In distribution | |
| 940-03-60I | In distribution | |
| 942-01-28B | In distribution | |
| 940-01-42A | In distribution | |
| 941-01-44I | In distribution | |
| 943-01-36E | In distribution | |
| 940-01-56H | In distribution | |
| 940-02-68K | In distribution | |
| 944-01-28B | In distribution | |
| 943-01-40H | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CS2 Acet. Cup Sys. – VitalitE | Shalby Advanced Technologies, Inc. | 169 |
| iTotal® Hip Replacement System | ConforMIS, Inc. | 131 |
| CS2 Acet. Cup Sys. – VitalitE | Consensus Orthopedics, Inc. | 124 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172651 | 2017-12-13 |
| K140130 | 2014-11-06 |
| K130365 | 2013-09-23 |
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|
| Encore Medical, L.P. | 510(k) number | 2026-01-05 | Class II | Labeling Change Control | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices o | 49 |
| Encore Medical, L.P. | 510(k) number | 2023-08-22 | Class II | Labeling Change Control | Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee) | 20 |
| Encore Medical, L.P. | 510(k) number | 2022-08-12 | Class II | Process control | Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery. | 4 |
| Encore Medical, L.P. | 510(k) number | 2020-09-09 | Class II | Employee error | Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly. | 12 cups |
| Encore Medical, L.P. | 510(k) number | 2019-10-22 | Class II | Device Design | The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space. | 86 units |
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.