Gender Solutions® Natural-Knee® Prolong®
33 catalogue numbers from 00-5420-010-03, listed by Zimmer, Inc., United States, under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
33catalogue numbers in this listing
19510(k) clearances naming this product code
29recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 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 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K070214 |
| Record published | 2015-09-17 |
| Record revised | 2021-02-05 (version 5) |
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 |
|---|---|---|
| 00-5420-010-03 | Size 3, 10 mm, Thickness | In distribution |
| 00-5428-021-16 | Height 16 mm | In distribution |
| 00-5424-021-09 | Size 1,2 | In distribution |
| 00-5424-013-11 | Size 3,4,5 | In distribution |
| 00-5428-023-09 | Size 3,4,5 | In distribution |
| 00-5428-011-16 | Height 16 mm | In distribution |
| 00-5424-020-11 | Size 00,0 | In distribution |
| 00-5424-011-11 | Height 11 mm | In distribution |
| 00-5428-010-16 | Height 16 mm | In distribution |
| 00-5428-013-09 | Height 9 mm | In distribution |
| 00-5424-011-13 | Size 1,2 | In distribution |
| 00-5424-020-09 | Size 00,0 | In distribution |
| 00-5428-020-11 | Size 00,0 | In distribution |
| 00-5424-023-16 | Height 16 mm | In distribution |
| 00-5428-020-19 | Size 00,0 | In distribution |
| 00-5428-011-11 | Size 1,2 | In distribution |
| 00-5428-021-13 | Height 13 mm | In distribution |
| 00-5424-023-13 | Height 13 mm | In distribution |
| 00-5424-023-11 | Height 11 mm | In distribution |
| 00-5424-011-19 | Height 19 mm | In distribution |
| 00-5428-010-11 | Size 00,0 | In distribution |
| 00-5424-023-19 | Size 3,4,5 | In distribution |
| 00-5428-013-11 | Size 3,4,5 | In distribution |
| 00-5428-013-16 | Height 16 mm | In distribution |
| 00-5424-023-09 | Height 9 mm | In distribution |
| 00-5424-021-19 | Height 19 mm | In distribution |
| 00-5428-020-09 | Size 00,0 | In distribution |
| 00-5420-008-01 | Size 1, 8 mm, Thickness | In distribution |
| 00-5424-010-19 | Size 00,0 | In distribution |
| 00-5424-013-19 | Height 19 mm | In distribution |
| 00-5428-021-19 | Height 19 mm | In distribution |
| 00-5424-013-09 | Size 3,4,5 | In distribution |
| 00-5424-021-11 | Size 1,2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| Attune | Depuy (Ireland) | 234 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251840 | 2026-05-28 |
| K253189 | 2026-03-09 |
| K242543 | 2024-11-22 |
| K243247 | 2024-10-29 |
| K240299 | 2024-04-26 |
| K222566 | 2022-10-17 |
| K172524 | 2018-05-17 |
| K173417 | 2018-01-30 |
| K150090 | 2015-05-20 |
| K141840 | 2014-09-03 |
| K123459 | 2013-02-22 |
| K122745 | 2012-12-05 |
| K121771 | 2012-11-07 |
| K072619 | 2007-11-21 |
| K072160 | 2007-09-05 |
| K071107 | 2007-07-06 |
| K070214 | 2007-03-16 |
| K041100 | 2004-10-29 |
| K031061 | 2003-10-09 |
Recalls Naming This Product
73 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 | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 61485 | 2017-05-23 |
| Zimmer, Inc. | 510(k) number | 2014-07-10 | Class II | Device Design | Zimmer received a trend of complaints indicating corrosion of product. | 8638 distribution events | 2015-08-20 |
| Zimmer, Inc. | 510(k) number | 2014-07-10 | Class II | Device Design | Zimmer received a trend of complaints indicating corrosion of product. | 8638 distribution events | 2015-08-20 |
| Zimmer, Inc. | 510(k) number | 2014-07-10 | Class II | Device Design | Zimmer received a trend of complaints indicating corrosion of product. | 8638 distribution events | 2015-08-20 |
| Zimmer, Inc. | 510(k) number | 2014-07-10 | Class II | Device Design | Zimmer received a trend of complaints indicating corrosion of product. | 8638 distribution events | 2015-08-20 |
| Zimmer, Inc. | 510(k) number | 2014-02-25 | Class II | Storage | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being | 3638 units | 2015-03-24 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
| Zimmer, Inc. | 510(k) number | 2009-10-08 | Not classified | Other | The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device. | 26,404 of all products | 2011-05-16 |
Showing 40 of 73.
Recalls
13 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 |
|---|---|---|---|---|---|
| 2026-05-11 | Class II | Labeling Change Control | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. | 12 | |
| 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. | 2020-04-02 | |
| 2016-05-11 | Class II | Component design/selection | Zimmer Inc. is initiating a recall of specific Persona” Trabecular Metal” Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants. | 10,256 | 2017-06-02 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 18482 | 2017-05-23 |
| 2015-01-28 | Class II | Under Investigation by firm | An increase in complaints of loosening and radiolucent lines. | 11,658 | 2018-03-13 |
| 2012-04-30 | Class II | Component design/selection | The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off | 65 units | 2014-06-04 |
| 2012-04-30 | Class II | Component design/selection | The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off | 1662 units | 2014-06-04 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the inst | 556 | 2013-03-19 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. The firm has received 24 complaints of the spring breaking, four of which were reported that the patient had | 27 devices | 2013-08-28 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the inst | 323+409 (in addendum)=732 | 2013-03-19 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the inst | 99 | 2013-03-19 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the inst | 199+416(in addendum)=615 | 2013-03-19 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the inst | 548 | 2013-03-19 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the inst | 649 | 2013-03-19 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the inst | 578 | 2013-03-19 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. The firm has received 24 complaints of the spring breaking, four of which were reported that the patient had | 802 devices | 2013-08-28 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the inst | 802 | 2013-03-19 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the inst | 757 | 2013-03-19 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the inst | 320 | 2013-03-19 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the inst | 436+414(in addendum)=850 | 2013-03-19 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the inst | 207 | 2013-03-19 |
| 2011-03-14 | Not classified | Device Design | The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the inst | 552 | 2013-03-19 |
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.