Endo-Model Saddle Prosthesis
Base components with inside anti-rotation pin, incl. 4 setscrews
10manufacturers in China registered for this device type
24catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (2). 6 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| 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 | Waldemar Link GmbH & Co. KG, Germany |
|---|---|
| FDA product code | KWL |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K951355 |
| Record published | 2015-11-01 |
| Record revised | 2026-07-02 (version 7) |
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, serial number |
| Distribution end date | 2026-03-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 99-0090/35 | Size 5 | In distribution |
| 99-0090/37 | Size 7 | In distribution |
| 99-0090/34 | Size 4 | In distribution |
| 99-0090/36 | Size 6 | In distribution |
| 99-0090/33 | Size 3 | In distribution |
| 99-0090/32 | Size 2 | In distribution |
| 99-0090/31 | SIze 1 | In distribution |
| 99-8007/13 | Withdrawn | |
| 15-8007/36 | Size 6 | Withdrawn |
| 15-8007/26 | Withdrawn | |
| 99-8007/11 | Length=110mm | Withdrawn |
| 99-8007/14 | Length=140mm | Withdrawn |
| 15-8007/12 | Withdrawn | |
| 15-8007/37 | Size 7 | Withdrawn |
| 15-8007/13 | Withdrawn | |
| 15-8007/10 | Withdrawn | |
| 15-8007/22 | Size 2 | Withdrawn |
| 15-8007/11 | Withdrawn | |
| 15-8007/25 | Size 5 | Withdrawn |
| 15-8007/24 | Size 4 | Withdrawn |
| 15-8007/23 | Size 3 | Withdrawn |
| 99-8007/12 | Length=120mm | Withdrawn |
| 99-8007/15 | Length=150mm | Withdrawn |
| 15-8007/21 | Size 1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ustar II Knee System | United Orthopedic Corp. | 115 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 95 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 95 |
| Instrument | Howmedica Osteonics Corp | 94 |
| UHR | Howmedica Osteonics Corp | 75 |
| Austin Moore | Howmedica Osteonics Corp | 67 |
| B-P Total HIP System | Endotec, Inc. | 66 |
| CS2 Acetabular Cup System | Consensus Orthopedics, Inc. | 64 |
| DJO Surgical | Encore Medical, L.P. | 62 |
| Restoration | Howmedica Osteonics Corp | 56 |
| Optimom Modular Heads | Corin Limited | 49 |
| Corin Unipolar Modular Head | Corin Limited | 36 |
Showing 12 of 167. All products under Prosthesis, Hip, Hemi-, Femoral, Metal
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.