NexGen® Legacy® Gender Solutions®
12 catalogue numbers from 00-5761-016-91, 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
12catalogue 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) | K031061 |
| Record published | 2016-05-24 |
| Record revised | 2022-03-22 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-5761-016-91 | Size F | In distribution |
| 00-5761-014-81 | Size D | In distribution |
| 00-5761-017-91 | Size G | In distribution |
| 00-5761-014-91 | Size D | In distribution |
| 00-5761-017-82 | Size G | In distribution |
| 00-5761-013-92 | Size C | In distribution |
| 00-5761-017-81 | Size G | In distribution |
| 00-5761-013-91 | Size C | In distribution |
| 00-5761-015-82 | Size E | In distribution |
| 00-5761-015-81 | Size E | In distribution |
| 00-5761-016-82 | Size F | In distribution |
| 00-5761-013-82 | Size C | 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
22 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 | 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 | |
| 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. | 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 | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
| Zimmer, Inc. | 510(k) number | 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 |
Recalls
9 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 |
| 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 |
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.