Fitmore® Hip Stem
Fitmore Hip Stem B Ext. Offs., Size 9
14manufacturers in China registered for this device type
75catalogue numbers in this listing
5510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), 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 |
| 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 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | KWY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3390 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2017-11-28 |
| Record revised | 2023-06-27 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01.00559.202 | In distribution | |
| 01.00555.304 | In distribution | |
| 01.00559.201 | In distribution | |
| 01.00559.206 | In distribution | |
| 01.00559.306 | In distribution | |
| 01.00559.101 | In distribution | |
| 01.00555.104 | In distribution | |
| 01.00559.105 | In distribution | |
| 01.00551.309 | 9 | In distribution |
| 01.00559.114 | In distribution | |
| 01.00555.305 | In distribution | |
| 01.00551.413 | 13 | In distribution |
| 01.00559.213 | In distribution | |
| 01.00555.101 | In distribution | |
| 01.00559.251 | In distribution | |
| 01.00559.301 | In distribution | |
| 01.00555.102 | In distribution | |
| 01.00559.610 | In distribution | |
| 01.00555.610 | In distribution | |
| 01.00559.110 | In distribution | |
| 01.00559.314 | In distribution | |
| 01.00559.108 | In distribution | |
| 01.00555.301 | In distribution | |
| 01.00555.104 | In distribution | |
| 01.00555.302 | In distribution | |
| 01.00559.203 | In distribution | |
| 01.00555.304 | In distribution | |
| 01.00555.105 | In distribution | |
| 01.00555.103 | In distribution | |
| 01.00555.205 | In distribution | |
| 01.00559.309 | In distribution | |
| 01.00555.203 | In distribution | |
| 01.00559.104 | In distribution | |
| 01.00555.204 | In distribution | |
| 01.00559.311 | In distribution | |
| 01.00555.105 | In distribution | |
| 01.00559.112 | In distribution | |
| 01.00559.214 | In distribution | |
| 01.00559.111 | In distribution | |
| 01.00551.305 | 5 | In distribution |
| 01.00559.208 | In distribution | |
| 01.00559.304 | In distribution | |
| 01.00555.303 | In distribution | |
| 01.00559.113 | In distribution | |
| 01.00559.250 | In distribution | |
| 01.00559.312 | In distribution | |
| 01.00559.209 | In distribution | |
| 01.00555.202 | In distribution | |
| 01.00559.207 | In distribution | |
| 01.00555.303 | In distribution | |
| 01.00555.102 | In distribution | |
| 01.00559.350 | In distribution | |
| 01.00559.150 | In distribution | |
| 01.00555.103 | In distribution | |
| 01.00555.201 | In distribution | |
| 01.00559.204 | In distribution | |
| 01.00559.107 | In distribution | |
| 01.00555.203 | In distribution | |
| 01.00559.103 | In distribution | |
| 01.00559.310 | In distribution | |
| 01.00559.205 | In distribution | |
| 01.00559.303 | In distribution | |
| 01.00555.301 | In distribution | |
| 01.00559.102 | In distribution | |
| 01.00559.212 | In distribution | |
| 01.00555.201 | In distribution | |
| 01.00559.305 | In distribution | |
| 01.00555.205 | In distribution | |
| 01.00559.109 | In distribution | |
| 01.00555.202 | In distribution | |
| 01.00559.106 | In distribution | |
| 01.00559.211 | In distribution | |
| 01.00559.308 | In distribution | |
| 01.00559.307 | In distribution | |
| 01.00555.101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 196 |
| Corin Bipolar Prosthesis | Corin Limited | 182 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 177 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 177 |
| Instrument | Howmedica Osteonics Corp | 130 |
| Bencox Hip System | Corentec Co., Ltd. | 126 |
| United Hip System, U2 Bipolar Implant | United Orthopedic Corp. | 123 |
| MultiPolar® | Zimmer, Inc. | 100 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Zimmer, Inc. | 96 |
| Arcos® Modular Revision System | Biomet Orthopedics | 67 |
| Acumatch L-Series | Exactech, Inc. | 67 |
| Corin BiPolar-i | Corin Limited | 54 |
Showing 12 of 352. All products under Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192236 | 2019-11-05 |
| K170072 | 2017-02-07 |
| K884658 | 1988-11-30 |
| K872019 | 1987-07-21 |
| K833991 | 1984-01-30 |
Recalls
5 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 |
|---|---|---|---|---|---|
| 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 |
| 2016-01-11 | Class II | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. | 72806 | 2017-05-23 |
| 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 |
| 2013-08-30 | Class II | Package design/selection | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. | 72806 | 2014-09-25 |
| 2012-08-31 | Class II | Process design | Zimmer Inc. is initiating a removal of the Multipolar Bipolar Cup Liner 22 mm J.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled. | 195 | 2013-09-23 |
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.