Miller Galante II
3 catalogue numbers from CP0001913, listed by Biomet Orthopedics, 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
3catalogue numbers in this listing
2510(k) clearances naming this product 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 | Biomet Orthopedics, 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 |
| 510(k) | K892800 |
| Record published | 2020-01-17 |
| Record revised | 2025-05-30 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CP0001913 | 13mm Thickness | In distribution |
| CP0001914 | 15mm Thickness | In distribution |
| CP0001912 | 11mm Thickness | 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 |
|---|---|
| K080528 | 2008-06-17 |
| K022586 | 2002-08-15 |
Recalls Naming This Product
70 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 Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 0 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 512 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 3696 | 2017-04-13 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| Zimmer, Inc. | 510(k) number | 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
| Zimmer, Inc. | 510(k) number | 2012-02-24 | Not classified | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identif | 83,322 all sizes | 2014-04-18 |
Showing 40 of 70.
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.