Orthinox
V40 FEM Head
14manufacturers in China registered for this device type
1catalogue number
16510(k) clearances naming this product code
40recalls 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 | Howmedica Osteonics Corp, 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, Contract steriliser, Specification developer, Manufacturer |
| Record published | 2015-09-24 |
| Record revised | 2024-05-30 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 32 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6364-2-232 | Taper Connection: V40? | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Initia Total Hip System | Kyocera Medical Technologies, Inc. | 1,000 |
| DJO Surgical | Encore Medical, L.P. | 624 |
| 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 |
Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121308 | 2012-07-30 |
| K101072 | 2011-04-11 |
| K102019 | 2011-03-03 |
| K090897 | 2009-10-23 |
| K081171 | 2008-07-22 |
| K062419 | 2006-11-15 |
| K061434 | 2006-08-22 |
| K061168 | 2006-07-18 |
| K033716 | 2005-02-10 |
| K032581 | 2003-10-09 |
| K021911 | 2002-07-02 |
| K020497 | 2002-03-04 |
| K013475 | 2001-12-20 |
| K010170 | 2001-04-18 |
| K990849 | 1999-12-20 |
| K993352 | 1999-11-19 |
Recalls
35 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 |
|---|---|---|---|---|---|
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 3 units | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 45 units | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 0 | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 48 units | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 0 | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 225 units | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 0 | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 0 | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 0 | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 0 | |
| 2024-02-27 | Class II | Under Investigation by firm | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | 0 | |
| 2021-12-21 | Class II | Under Investigation by firm | There is a potential for the outer Tyvek lid to de-bond from the sealed package. | 8 units | |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 4895 | 2021-11-15 |
| 2020-04-16 | Class II | Packaging | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | 2021-11-15 | |
| 2019-10-03 | Class II | Employee error | Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015) | 40 units | 2022-04-21 |
| 2017-07-21 | Class II | Process control | Inner and outer sterile barriers not fully sealed. | 255 | 2020-03-12 |
| 2017-07-21 | Class II | Process control | Inner and outer sterile barriers not fully sealed. | 255 | 2020-03-12 |
| 2016-06-03 | Class II | Process design | Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method. | 1,864 units | 2018-08-01 |
| 2015-09-08 | Class II | Process design | Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery. | 201 | 2017-07-25 |
| 2015-06-25 | Class II | Nonconforming Material/Component | it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field. | 16 units | 2017-08-30 |
| 2014-08-15 | Class II | Under Investigation by firm | The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier. | 1,147 in total | 2018-01-05 |
| 2007-09-28 | Not classified | Packaging process control | Mis-labeling: The warning label “Do not use with heads more than +10mm offset” does not appear on 127 degree stem boxes. | 30 | 2008-10-27 |
| 2007-09-28 | Not classified | Packaging process control | Mis-labeling: The warning label “Do not use with heads more than +10mm offset” does not appear on 127 degree stem boxes. | 46 | 2008-10-27 |
| 2007-09-28 | Not classified | Other | Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of +12 should have been omitted. | 192 protocols | 2008-09-05 |
| 2007-09-28 | Not classified | Packaging process control | Mis-labeling: The warning label “Do not use with heads more than +10mm offset” does not appear on 127 degree stem boxes. | 44 | 2008-10-27 |
| 2007-09-28 | Not classified | Packaging process control | Mis-labeled: The warning label “Do not use with heads more than +10mm offset” does not appear on 127 degree stem boxes. | 59 | 2008-10-27 |
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.