Durasul®
56 catalogue numbers from 4376-32-053, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
56catalogue numbers in this listing
27510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| 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 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | 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 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K993259 |
| Record published | 2017-10-23 |
| Record revised | 2020-06-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Lumen/inner diameter 22 to 44 mm; outer diameter 41 to 81 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4376-32-053 | Lumen/Inner Diameter 32 mm | In distribution |
| 4376-28-069 | Lumen/Inner Diameter 28 mm | In distribution |
| 4376-44-067 | Outer Diameter 67 mm | In distribution |
| 4377-28-069 | Outer Diameter 69 mm | In distribution |
| 4377-28-065 | Outer Diameter 65 mm | In distribution |
| 4376-28-047 | Outer Diameter 47 mm | In distribution |
| 4376-22-057 | Outer Diameter 57 mm | In distribution |
| 4376-32-055 | Lumen/Inner Diameter 32 mm | In distribution |
| 4376-44-071 | Lumen/Inner Diameter 44 mm | In distribution |
| 4376-28-063 | Outer Diameter 63 mm | In distribution |
| 4376-38-075 | Lumen/Inner Diameter 38 mm | In distribution |
| 4376-28-055 | Outer Diameter 55 mm | In distribution |
| 4377-28-059 | Outer Diameter 59 mm | In distribution |
| 4377-28-047 | Lumen/Inner Diameter 28 mm | In distribution |
| 4376-38-079 | Outer Diameter 79 mm | In distribution |
| 4376-44-075 | Lumen/Inner Diameter 44 mm | In distribution |
| 4376-22-047 | Lumen/Inner Diameter 22 mm | In distribution |
| 4376-44-069 | Outer Diameter 69 mm | In distribution |
| 4376-28-079 | Lumen/Inner Diameter 28 mm | In distribution |
| 4377-32-081 | Lumen/Inner Diameter 32 mm | In distribution |
| 4376-38-063 | Lumen/Inner Diameter 38 mm | In distribution |
| 4376-38-081 | Lumen/Inner Diameter 38 mm | In distribution |
| 4376-32-069 | Lumen/Inner Diameter 32 mm | In distribution |
| 4376-28-061 | Outer Diameter 61 mm | In distribution |
| 4377-28-045 | Lumen/Inner Diameter 28 mm | In distribution |
| 4376-32-077 | Lumen/Inner Diameter 32 mm | In distribution |
| 4376-38-077 | Lumen/Inner Diameter 38 mm | In distribution |
| 4376-44-073 | Lumen/Inner Diameter 44 mm | In distribution |
| 4376-44-063 | Lumen/Inner Diameter 44 mm | In distribution |
| 4376-22-065 | Lumen/Inner Diameter 22 mm | In distribution |
| 4377-32-055 | Lumen/Inner Diameter 32 mm | In distribution |
| 4376-22-055 | Outer Diameter 55 mm | In distribution |
| 4376-38-061 | Lumen/Inner Diameter 38 mm | In distribution |
| 4377-32-059 | Lumen/Inner Diameter 32 mm | In distribution |
| 4376-22-053 | Outer Diameter 53 mm | In distribution |
| 4376-44-065 | Outer Diameter 65 mm | In distribution |
| 4376-32-059 | Lumen/Inner Diameter 32 mm | In distribution |
| 4376-22-049 | Lumen/Inner Diameter 22 mm | In distribution |
| 4377-32-063 | Outer Diameter 63 mm | In distribution |
| 4376-38-069 | Lumen/Inner Diameter 38 mm | In distribution |
| 4377-22-041 | Lumen/Inner Diameter 22 mm | In distribution |
| 4377-28-053 | Outer Diameter 53 mm | In distribution |
| 4376-32-061 | Outer Diameter 61 mm | In distribution |
| 4376-28-067 | Outer Diameter 67 mm | In distribution |
| 4377-28-051 | Outer Diameter 51 mm | In distribution |
| 4377-32-057 | Outer Diameter 57 mm | In distribution |
| 4376-32-081 | Lumen/Inner Diameter 32 mm | In distribution |
| 4376-28-045 | Lumen/Inner Diameter 28 mm | In distribution |
| 4377-28-057 | Lumen/Inner Diameter 28 mm | In distribution |
| 4376-28-081 | Lumen/Inner Diameter 28 mm | In distribution |
| 4377-28-067 | Outer Diameter 67 mm | In distribution |
| 4377-32-053 | Outer Diameter 53 mm | In distribution |
| 4376-32-071 | Lumen/Inner Diameter 32 mm | In distribution |
| 4377-28-061 | Lumen/Inner Diameter 28 mm | In distribution |
| 4376-32-073 | Lumen/Inner Diameter 32 mm | In distribution |
| 4377-32-073 | Outer Diameter 73 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210842 | 2021-12-10 |
| K191449 | 2020-07-16 |
| K200823 | 2020-07-09 |
| K191735 | 2020-03-20 |
| K051516 | 2005-07-27 |
| K050105 | 2005-05-17 |
| K030153 | 2003-04-01 |
| K030265 | 2003-03-04 |
| K001733 | 2000-06-20 |
| K963109 | 1997-01-09 |
| K960278 | 1996-07-25 |
| K960658 | 1996-07-16 |
| K955473 | 1996-02-16 |
| K954744 | 1996-01-23 |
| K950312 | 1995-05-17 |
| K944792 | 1995-04-26 |
| K913649 | 1991-11-13 |
| K902436 | 1990-08-29 |
| K901364 | 1990-05-18 |
| K874229 | 1987-11-03 |
| K842906 | 1984-08-24 |
| K840643 | 1984-04-17 |
| K833912 | 1983-12-22 |
| K821893 | 1982-09-14 |
| K812182 | 1981-08-18 |
| K811293 | 1981-06-24 |
| K770908 | 1977-05-23 |
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2023-02-27 | Class II | Under Investigation by firm | Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in fl | 1,168 untits | |
| Zimmer, Inc. | 510(k) number | 2014-12-17 | Class II | Package design/selection | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic inf | 1908 | 2015-09-23 |
| Zimmer, Inc. | 510(k) number | 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 1000 | 2014-04-16 |
Recalls
40 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 |
|---|---|---|---|---|---|
| 2024-07-02 | Class II | Under Investigation by firm | Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF. | 5,500 (US); 242,000 (OUS) | |
| 2023-07-26 | Class II | Mixed-up of materials/components | The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa. | 24 units | |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 2022-05-20 | |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 2022-05-20 | |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 2022-05-20 | |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
| 2020-09-24 | Class II | Device Design | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions. | 412 units total | 2022-05-20 |
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.