Ti Cancellous Screw
The U-Motion II Acetabular System filing names Ti Cancellous Screws as fixation components for the metal acetabular shell. The filing describes these screws as self-tapping, 6.5 mm in…
The U-Motion II Acetabular System filing names Ti Cancellous Screws as fixation components for the metal acetabular shell.
The filing describes these screws as self-tapping, 6.5 mm in diameter and available in lengths from 15 to 60 mm.
Listed Item
Ti Cancellous Screw, Ø6.5 x 25mm
Fixation Role and Dimensions
The acetabular shell has clustered-hole and multi-hole versions for screw fixation. Screw-hole covers are also available when desired. These statements place the listed screw within the acetabular system and identify its function and size range.
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (3), Zhejiang (2). 10 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 |
| 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 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 15. All 15 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Record
| Listed by | United Orthopedic Corp., Taiwan |
|---|---|
| FDA product code | LZO |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K122185 |
| Record published | 2015-10-24 |
| Record revised | 2018-08-07 (version 4) |
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 | Length 15 to 60 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5206-1025 | Length 25 mm | In distribution |
| 5206-1040 | Ø6.5 | In distribution |
| 5206-1030 | Ø6.5 | In distribution |
| 5206-1035 | Length 35 mm | In distribution |
| 5206-1060 | Ø6.5 | In distribution |
| 5206-1015 | Length 15 mm | In distribution |
| 5206-1020 | Ø6.5 | In distribution |
| 5206-1055 | Length 55 mm | In distribution |
| 5206-1045 | Length 45 mm | In distribution |
| 5206-1050 | Ø6.5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Libertas | Maxx Orthopedics Inc. | 1,832 |
| Redapt | Smith & Nephew, Inc. | 326 |
| Bencox Hip System | Corentec Co., Ltd. | 295 |
| M-Vizion Femoral Revision System | Medacta International SA | 289 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Zimmer, Inc. | 280 |
| Profemur® | Microport Orthopedics Inc. | 229 |
| DJO Surgical | Encore Medical, L.P. | 162 |
| Instrument | Howmedica Osteonics Corp | 152 |
| Alteon | Exactech, Inc. | 151 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Exactech, Inc. | 136 |
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 136 |
| Wagner SL Revision® | Zimmer, Inc. | 133 |
Showing 12 of 691. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253948 | 2026-09-02 |
| K243466 | 2025-01-06 |
| K242249 | 2024-08-30 |
| K221149 | 2023-01-05 |
| K183312 | 2019-08-08 |
| K170089 | 2017-10-06 |
| K163441 | 2017-08-25 |
| K152530 | 2016-03-14 |
| K132455 | 2013-09-03 |
| K122185 | 2013-02-22 |
| K112463 | 2011-09-23 |
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.