Natural-Knee® Durasul®
30 catalogue numbers from 6276-02-719, listed by Zimmer, Inc., United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
30catalogue numbers in this listing
51510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K002335 |
| Record published | 2015-09-17 |
| Record revised | 2019-09-25 (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 | Height 9 to 19 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6276-02-719 | Height 19 mm | In distribution |
| 6276-01-613 | Height 13 mm | In distribution |
| 6276-01-616 | Size 1, 2 | In distribution |
| 6276-01-716 | Height 16 mm | In distribution |
| 6276-02-613 | Size 3, 4, 5 | In distribution |
| 6276-02-711 | Size 3, 4, 5 | In distribution |
| 6276-00-713 | Size 00, 0 | In distribution |
| 6276-00-609 | Size 00, 0 | In distribution |
| 6276-01-709 | Height 9 mm | In distribution |
| 6276-02-616 | Height 16 mm | In distribution |
| 6276-02-611 | Size 3, 4, 5 | In distribution |
| 6276-00-709 | Size 00, 0 | In distribution |
| 6276-00-711 | Size 00, 0 | In distribution |
| 6276-00-619 | Size 00, 0 | In distribution |
| 6276-00-613 | Height 13 mm | In distribution |
| 6276-00-616 | Size 00, 0 | In distribution |
| 6276-00-611 | Height 11 mm | In distribution |
| 6276-01-713 | Height 13 mm | In distribution |
| 6276-02-716 | Height 16 mm | In distribution |
| 6276-02-609 | Height 9 mm | In distribution |
| 6276-01-619 | Height 19 mm | In distribution |
| 6276-02-713 | Size 3, 4, 5 | In distribution |
| 6276-02-709 | Height 9 mm | In distribution |
| 6276-01-611 | Height 11 mm | In distribution |
| 6276-02-619 | Size 3, 4, 5 | In distribution |
| 6276-01-719 | Size 1, 2 | In distribution |
| 6276-01-609 | Height 9 mm | In distribution |
| 6276-00-716 | Size 00, 0 | In distribution |
| 6276-00-719 | Height 19 mm | In distribution |
| 6276-01-711 | Size 1, 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243724 | 2025-03-06 |
| K230321 | 2023-03-08 |
| K221479 | 2022-11-17 |
| K210829 | 2021-05-18 |
| K210551 | 2021-03-18 |
| K200209 | 2020-03-24 |
| K193223 | 2020-01-24 |
| K191625 | 2019-09-05 |
| K190068 | 2019-06-04 |
| K183583 | 2019-05-10 |
| K181947 | 2018-10-25 |
| K173057 | 2018-03-29 |
| K152494 | 2015-11-25 |
| K142787 | 2014-12-22 |
| K133737 | 2014-02-04 |
| K130143 | 2013-02-22 |
| K122765 | 2012-11-09 |
| K113369 | 2012-03-27 |
| K073286 | 2008-03-07 |
| K072281 | 2007-09-06 |
| K062768 | 2006-10-13 |
| K061882 | 2006-08-01 |
| K060722 | 2006-05-26 |
| K060370 | 2006-04-28 |
| K052879 | 2005-11-22 |
| K050723 | 2005-04-20 |
| K043101 | 2005-03-07 |
| K042271 | 2004-10-13 |
| K023211 | 2002-10-17 |
| K013991 | 2001-12-27 |
| K003910 | 2001-03-19 |
| K991581 | 1999-07-30 |
| K972774 | 1999-05-05 |
| K972270 | 1997-11-24 |
| K963148 | 1997-02-13 |
| K962196 | 1996-08-23 |
| K960279 | 1996-04-26 |
| K951185 | 1996-03-15 |
| K946150 | 1995-07-11 |
| K933785 | 1995-01-30 |
| K930831 | 1993-11-16 |
| K911572 | 1991-07-01 |
| K895639 | 1990-02-08 |
| K892800 | 1989-08-03 |
| K872379 | 1987-10-28 |
| K863805 | 1986-12-02 |
| K853661 | 1985-12-09 |
| K834432 | 1984-04-11 |
| K833363 | 1984-02-13 |
| K830121 | 1983-04-26 |
| K790219 | 1979-05-08 |
Recalls Naming This Product
10 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 | 2023-05-19 | Class II | Under Investigation by firm | Device outer packaging was incorrectly labeled. | 2026-05-29 | |
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| Zimmer, Inc. | 510(k) number | 2011-12-21 | Not classified | Component design/selection | The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highl | TBD | 2015-08-21 |
| Zimmer, Inc. | 510(k) number | 2011-12-21 | Not classified | Component design/selection | The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highl | 2015-08-21 | |
| Zimmer, Inc. | 510(k) number | 2011-12-21 | Not classified | Component design/selection | The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highl | 2015-08-21 | |
| Zimmer, Inc. | 510(k) number | 2011-12-21 | Not classified | Component design/selection | The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highl | 2015-08-21 | |
| Zimmer, Inc. | 510(k) number | 2011-12-21 | Not classified | Component design/selection | The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highl | 2015-08-21 | |
| Zimmer, Inc. | 510(k) number | 2011-12-21 | Not classified | Component design/selection | The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highl | 2015-08-21 | |
| Zimmer, Inc. | 510(k) number | 2011-12-21 | Not classified | Component design/selection | The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highl | 2015-08-21 | |
| Zimmer, Inc. | 510(k) number | 2011-12-21 | Not classified | Component design/selection | The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highl | 2015-08-21 |
Recalls
38 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 |
|---|---|---|---|---|---|
| 2025-02-27 | Class II | Labeling Change Control | The “Use with plate 7, 8, 9, 10” compatibility statement on top of the label does not match with the compatibility statements “USE WITH PLATE 5, 6” in the translations section of the same label. | 76 units | |
| 2025-01-06 | Class II | Process change control | It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. | 155 units | |
| 2025-01-06 | Class II | Process change control | It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. | 155 units | |
| 2024-03-28 | Class II | Process change control | Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate. | 5,546 units | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1366 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1049 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 1673 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 2092 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 284 | |
| 2022-12-06 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used wit | 2460 | |
| 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| 2018-10-31 | Class II | Process control | Screw is missing from the package | 19 units | 2019-04-08 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-11-29 | Class II | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. | 13,227 in total | 2020-04-02 |
| 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| 2017-08-07 | Class II | Under Investigation by firm | There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the | 842 products in total | 2018-08-23 |
| 2017-04-28 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorr | 24 | 2018-07-03 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 32508 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 88389 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 117359 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 42064 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 61485 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 18093 | 2017-05-23 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 84396 | 2017-05-23 |
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.