DJO Surgical
Liner, Acetabular, Hooded, Neutral, 10-¦, HXL/FMP, 40MM ID, MP12
14manufacturers in China registered for this device type
624catalogue numbers in this listing
12510(k) clearances naming this product code
12recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 10 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| 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 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | LPH |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K000521 |
| Record published | 2017-08-07 |
| Record revised | 2020-09-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| 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 |
|---|---|---|
| 430-05-064 | In distribution | |
| 430-99-048 | In distribution | |
| 492-15-205 | In distribution | |
| 400-00-445 | In distribution | |
| 430-02-062 | In distribution | |
| 932-40-264 | In distribution | |
| 430-02-060 | In distribution | |
| 430-02-042 | In distribution | |
| 944-01-32H | In distribution | |
| 497-40-000 | In distribution | |
| 933-36-280 | In distribution | |
| 934-36-252 | In distribution | |
| 430-98-040 | In distribution | |
| 430-07-072 | In distribution | |
| 430-07-058 | In distribution | |
| 429-12-100 | In distribution | |
| 430-01-066 | In distribution | |
| 430-93-054 | In distribution | |
| 803-15-112 | In distribution | |
| 940-02-42A | In distribution | |
| 429-00-140 | In distribution | |
| 803-15-146 | In distribution | |
| 940-03-70K | In distribution | |
| 430-07-070 | In distribution | |
| 427-44-150 | In distribution | |
| 430-02-058 | In distribution | |
| 400-00-442 | In distribution | |
| 433-22-205 | In distribution | |
| 430-93-068 | In distribution | |
| 933-36-752 | In distribution | |
| 430-93-058 | In distribution | |
| 400-00-323 | In distribution | |
| 400-00-403 | In distribution | |
| 430-96-040 | In distribution | |
| 433-32-708 | In distribution | |
| 430-03-062 | In distribution | |
| 490-00-135 | In distribution | |
| 940-03-44B | In distribution | |
| 430-96-054 | In distribution | |
| 933-44-268 | In distribution | |
| 430-03-048 | In distribution | |
| 492-22-180 | In distribution | |
| 430-04-058 | In distribution | |
| 430-94-042 | In distribution | |
| 432-32-711 | In distribution | |
| 430-07-050 | In distribution | |
| 492-23-205 | In distribution | |
| 425-41-006 | In distribution | |
| 430-93-074 | In distribution | |
| 427-03-180 | In distribution | |
| 932-40-756 | In distribution | |
| 492-20-180 | In distribution | |
| 933-28-248 | In distribution | |
| 427-03-090 | In distribution | |
| 951-01-54J | In distribution | |
| 400-00-401 | In distribution | |
| 430-96-070 | In distribution | |
| 430-07-046 | In distribution | |
| 429-00-120 | In distribution | |
| 951-01-42F | In distribution | |
| 430-01-062 | In distribution | |
| 942-01-40G | In distribution | |
| 943-01-44K | In distribution | |
| 430-05-046 | In distribution | |
| 400-00-364 | In distribution | |
| 952-28-40E | In distribution | |
| 431-28-105 | In distribution | |
| 803-15-154 | In distribution | |
| 492-19-180 | In distribution | |
| 425-31-014 | In distribution | |
| 427-34-135 | In distribution | |
| 433-22-203 | In distribution | |
| 432-32-709 | In distribution | |
| 952-28-50I | In distribution | |
| 497-34-000 | In distribution | |
| 932-36-276 | In distribution | |
| 400-00-322 | In distribution | |
| 935-44-280 | In distribution | |
| 430-96-058 | In distribution | |
| 490-00-000 | In distribution | |
| 932-40-260 | In distribution | |
| 430-98-044 | In distribution | |
| 430-97-068 | In distribution | |
| 944-01-40F | In distribution | |
| 430-98-058 | In distribution | |
| 400-00-363 | In distribution | |
| 932-44-260 | In distribution | |
| 430-07-080 | In distribution | |
| 490-00-180 | In distribution | |
| 430-06-044 | In distribution | |
| 944-01-36H | In distribution | |
| 944-01-40K | In distribution | |
| 430-04-060 | In distribution | |
| 942-01-40F | In distribution | |
| 931-44-764 | In distribution | |
| 952-28-46H | In distribution | |
| 430-04-040 | In distribution | |
| 940-03-56H | In distribution | |
| 932-40-280 | In distribution | |
| 430-02-052 | In distribution | |
| 492-23-180 | In distribution | |
| 931-40-280 | In distribution | |
| 430-04-050 | In distribution | |
| 931-44-280 | In distribution | |
| 430-99-066 | In distribution | |
| 940-03-54G | In distribution | |
| 430-96-066 | In distribution | |
| 934-36-264 | In distribution | |
| 431-32-710 | In distribution | |
| 940-01-64J | In distribution | |
| 431-32-708 | In distribution | |
| 932-32-250 | In distribution | |
| 951-01-44G | In distribution | |
| 430-05-044 | In distribution | |
| 492-20-205 | In distribution | |
| 933-28-748 | In distribution | |
| 400-00-285 | In distribution | |
| 492-24-180 | In distribution | |
| 431-28-109 | In distribution | |
| 430-07-074 | In distribution | |
| 431-22-703 | In distribution | |
| 932-36-256 | In distribution | |
| 931-34-250 | In distribution | |
| 430-01-070 | In distribution | |
| 941-01-44J | In distribution | |
| 430-94-046 | In distribution | |
| 430-94-060 | In distribution | |
| 940-03-48D | In distribution | |
| 430-01-054 | In distribution | |
| 430-03-042 | In distribution | |
| 425-31-012 | In distribution | |
| 430-01-058 | In distribution | |
| 430-93-042 | In distribution | |
| 433-32-710 | In distribution | |
| 942-01-36G | In distribution | |
| 430-93-080 | In distribution | |
| 430-94-066 | In distribution | |
| 803-15-138 | In distribution | |
| 940-00-015 | In distribution | |
| 430-98-048 | In distribution | |
| 934-44-268 | In distribution | |
| 427-03-105 | In distribution | |
| 430-98-054 | In distribution | |
| 934-28-248 | In distribution | |
| 940-01-68K | In distribution | |
| 492-14-180 | In distribution | |
| 933-36-252 | In distribution | |
| 430-03-070 | In distribution | |
| 430-93-060 | In distribution | |
| 803-15-113 | In distribution | |
| 430-02-044 | In distribution | |
| 430-07-040 | In distribution | |
| 935-36-280 | In distribution | |
| 935-28-248 | In distribution | |
| 430-99-052 | In distribution | |
| 430-03-056 | In distribution | |
| 431-28-108 | In distribution | |
| 932-44-760 | In distribution | |
| 425-92-016 | In distribution | |
| 430-07-068 | In distribution | |
| 932-44-264 | In distribution | |
| 934-44-280 | In distribution | |
| 944-01-44K | In distribution | |
| 430-98-042 | In distribution | |
| 430-01-056 | In distribution | |
| 942-01-28C | In distribution | |
| 430-93-046 | In distribution | |
| 430-93-052 | In distribution | |
| 433-32-709 | In distribution | |
| 940-01-60I | In distribution | |
| 932-44-768 | In distribution | |
| 430-97-040 | In distribution | |
| 427-44-120 | In distribution | |
| 432-32-210 | In distribution | |
| 931-44-768 | In distribution | |
| 430-96-060 | In distribution | |
| 430-04-042 | In distribution | |
| 429-18-100 | In distribution | |
| 944-01-36F | In distribution | |
| 400-00-284 | In distribution | |
| 931-36-260 | In distribution | |
| 430-07-076 | In distribution | |
| 492-14-205 | In distribution | |
| 940-00-020 | In distribution | |
| 497-28-105 | In distribution | |
| 943-01-36G | In distribution | |
| 943-01-36K | In distribution | |
| 941-01-40F | In distribution | |
| 430-07-044 | In distribution | |
| 400-00-444 | In distribution | |
| 430-03-050 | In distribution | |
| 931-40-264 | In distribution | |
| 400-00-365 | In distribution | |
| 935-44-276 | In distribution | |
| 431-28-110 | In distribution | |
| 931-32-750 | In distribution | |
| 492-24-205 | In distribution | |
| 944-01-32E | In distribution | |
| 940-01-48D | In distribution | |
| 430-01-068 | In distribution | |
| 933-44-768 | In distribution | |
| 430-02-064 | In distribution | |
| 430-94-064 | In distribution | |
| 941-01-32B | In distribution | |
| 492-17-205 | In distribution | |
| 942-01-40J | In distribution | |
| 932-40-268 | In distribution | |
| 430-04-064 | In distribution | |
| 933-36-276 | In distribution | |
| 427-04-090 | In distribution | |
| 425-31-006 | In distribution | |
| 931-28-748 | In distribution | |
| 430-04-066 | In distribution | |
| 430-03-066 | In distribution | |
| 430-94-058 | In distribution | |
| 400-00-281 | In distribution | |
| 430-97-042 | In distribution | |
| 931-40-260 | In distribution | |
| 931-40-276 | In distribution | |
| 430-03-046 | In distribution | |
| 932-28-248 | In distribution | |
| 431-32-712 | In distribution | |
| 934-36-272 | In distribution | |
| 400-00-321 | In distribution | |
| 430-04-062 | In distribution | |
| 427-44-080 | In distribution | |
| 931-36-268 | In distribution | |
| 430-01-048 | In distribution | |
| 425-93-006 | In distribution | |
| 931-28-246 | In distribution | |
| 940-03-68K | In distribution | |
| 430-07-042 | In distribution | |
| 430-96-064 | In distribution | |
| 935-44-272 | In distribution | |
| 430-01-040 | In distribution | |
| 942-01-36I | In distribution | |
| 931-44-272 | In distribution | |
| 942-01-44I | In distribution | |
| 430-93-050 | In distribution | |
| 931-44-260 | In distribution | |
| 932-28-748 | In distribution | |
| 432-32-710 | In distribution | |
| 425-41-017 | In distribution | |
| 430-99-046 | In distribution | |
| 933-28-246 | In distribution | |
| 935-36-254 | In distribution | |
| 932-40-276 | In distribution | |
| 430-05-058 | In distribution | |
| 430-94-070 | In distribution | |
| 433-22-204 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Initia Total Hip System | Kyocera Medical Technologies, Inc. | 1,000 |
| Pinnacle | Depuy Orthopaedics, Inc. | 613 |
| Trilogy® Longevity® | Zimmer, Inc. | 564 |
| Instrument | Howmedica Osteonics Corp | 369 |
| InSitu Hip System | Nextstep Arthropedix | 368 |
| Trilogy® | Zimmer, Inc. | 359 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 298 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Zimmer, Inc. | 286 |
| Bencox Hip System | Corentec Co., Ltd. | 286 |
| OrthoMedFlex | Orthomedflex LLC | 257 |
| Sterizo Total Hip System | CPM Medical Consultants, LLC. | 240 |
| VerSys® | Zimmer, Inc. | 229 |
Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251833 | 2025-11-12 |
| K203557 | 2021-02-10 |
| K190057 | 2019-06-07 |
| K130099 | 2013-06-21 |
| K122636 | 2012-11-02 |
| K121024 | 2012-06-19 |
| K120241 | 2012-02-24 |
| K081679 | 2008-08-20 |
| K072888 | 2008-01-10 |
| K072154 | 2007-12-14 |
| K070050 | 2007-05-23 |
| K063257 | 2006-11-22 |
Recalls Naming This Product
13 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 |
|---|---|---|---|---|---|---|---|
| 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 | 2025-06-12 | Class II | Process control | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint. | 20 units | |
| Encore Medical, L.P. | 510(k) number | 2025-06-12 | Class II | Process control | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint. | 20 units | |
| 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 | |
| Encore Medical, L.P. | 510(k) number | 2014-02-07 | Class II | Packaging process control | Packaging error — two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other’s outer boxes after sterilization, resulting in the products being mislabeled. The units lab | 10 units of Model/Catalog Number 931-28-248 Lot/Serial Numbe | 2014-10-01 |
| Encore Medical, L.P. | 510(k) number | 2008-05-08 | Not classified | Nonconforming Material/Component | Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12. | 20 units | 2009-09-08 |
| Encore Medical, L.P. | 510(k) number | 2007-04-12 | Not classified | Other | Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. | 3 units. | 2007-07-25 |
| Encore Medical, L.P. | 510(k) number | 2007-04-12 | Not classified | Other | Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. | 3 units. | 2007-07-25 |
| Encore Medical, L.P. | 510(k) number | 2007-04-12 | Not classified | Other | Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. | 2 units. | 2007-07-25 |
| Encore Medical, L.P. | 510(k) number | 2007-04-12 | Not classified | Other | Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. | 2 units. | 2007-07-25 |
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 |
|---|---|---|---|---|---|
| 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. | 18 | |
| 2018-07-10 | Class II | Process design | The retaining ring on the neck trials has a potential to fail interoperatively. | 28 (14 REF S200635 and 14 S200636) | |
| 2016-06-21 | Class II | Process design | Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck. | 14 (7 sets) | 2017-01-10 |
| 2006-01-12 | Not classified | Other | Voids in the porous coating of a component used in total hip replacement surgery. | Total of 30 units | 2006-07-11 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P880025 | 1991-12-04 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy Intl., Ltd. |
| P880076 | 1991-06-17 | WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS | Dow Corning Wright |
| P850061 | 1991-03-08 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. |
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.