Legend
Acetabular Liner Face Changing 32/64-70
15manufacturers in China registered for this device type
66catalogue numbers in this listing
6510(k) clearances naming this product code
5recalls on this code
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 | Ortho Development Corp., United States |
|---|---|
| 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 | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K103384 |
| Record published | 2018-10-17 |
| Record revised | 2020-09-09 (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 |
| Sizes | Outer diameter 42 to 64 mm; lumen/inner diameter 28 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 174-3256 | Outer Diameter 56 mm | In distribution |
| 172-4062 | Lumen/Inner Diameter 40 mm | In distribution |
| 174-4056 | Lumen/Inner Diameter 40 mm | In distribution |
| 175-2848 | Outer Diameter 48 mm | In distribution |
| 173-3254 | Outer Diameter 54 mm | In distribution |
| 173-2854 | Outer Diameter 58 mm | In distribution |
| 172-3662 | Outer Diameter 62 mm | In distribution |
| 174-2844 | Lumen/Inner Diameter 28 mm | In distribution |
| 172-4064 | Lumen/Inner Diameter 40 mm | In distribution |
| 172-2852 | Lumen/Inner Diameter 28 mm | In distribution |
| 173-4056 | Outer Diameter 56 mm | In distribution |
| 174-3250 | Outer Diameter 50 mm | In distribution |
| 172-3264 | Outer Diameter 64 mm | In distribution |
| 174-3258 | Outer Diameter 58 mm | In distribution |
| 175-2860 | Lumen/Inner Diameter 28 mm | In distribution |
| 173-2842 | Outer Diameter 46 mm | In distribution |
| 173-4064 | Lumen/Inner Diameter 40 mm | In distribution |
| 175-3264 | Lumen/Inner Diameter 32 mm | In distribution |
| 174-4062 | Outer Diameter 62 mm | In distribution |
| 172-3256 | Outer Diameter 56 mm | In distribution |
| 175-3658 | Lumen/Inner Diameter 36 mm | In distribution |
| 175-2850 | Outer Diameter 50 mm | In distribution |
| 175-2856 | Lumen/Inner Diameter 28 mm | In distribution |
| 175-4060 | Outer Diameter 60 mm | In distribution |
| 172-3260 | Outer Diameter 60 mm | In distribution |
| 175-3258 | Lumen/Inner Diameter 32 mm | In distribution |
| 173-3652 | Outer Diameter 52 mm | In distribution |
| 174-2852 | Lumen/Inner Diameter 28 mm | In distribution |
| 175-2862 | Outer Diameter 62 mm | In distribution |
| 173-4054 | Outer Diameter 54 mm | In distribution |
| 174-3662 | Outer Diameter 62 mm | In distribution |
| 174-3658 | Lumen/Inner Diameter 36 mm | In distribution |
| 173-3662 | Outer Diameter 62 mm | In distribution |
| 172-3658 | Lumen/Inner Diameter 36 mm | In distribution |
| 174-3248 | Lumen/Inner Diameter 32 mm | In distribution |
| 173-3248 | Outer Diameter 48 mm | In distribution |
| 172-2864 | Lumen/Inner Diameter 28 mm | In distribution |
| 175-3260 | Outer Diameter 60 mm | In distribution |
| 173-2852 | Outer Diameter 56 mm | In distribution |
| 173-3246 | Outer Diameter 46 mm | In distribution |
| 175-2846 | Outer Diameter 46 mm | In distribution |
| 172-2848 | Lumen/Inner Diameter 28 mm | In distribution |
| 175-2858 | Lumen/Inner Diameter 28 mm | In distribution |
| 172-2842 | Outer Diameter 42 mm | In distribution |
| 172-2860 | Outer Diameter 60 mm | In distribution |
| 175-2842 | Outer Diameter 42 mm | In distribution |
| 174-2850 | Outer Diameter 50 mm | In distribution |
| 173-2860 | Lumen/Inner Diameter 28 mm | In distribution |
| 173-3658 | Outer Diameter 58 mm | In distribution |
| 174-3654 | Outer Diameter 54 mm | In distribution |
| 174-4064 | Outer Diameter 64 mm | In distribution |
| 172-3252 | Lumen/Inner Diameter 32 mm | In distribution |
| 175-3248 | Lumen/Inner Diameter 32 mm | In distribution |
| 175-3660 | Lumen/Inner Diameter 36 mm | In distribution |
| 175-2844 | Lumen/Inner Diameter 28 mm | In distribution |
| 174-3252 | Lumen/Inner Diameter 32 mm | In distribution |
| 174-3260 | Outer Diameter 60 mm | In distribution |
| 173-2844 | Outer Diameter 48 mm | In distribution |
| 172-4058 | Outer Diameter 58 mm | In distribution |
| 175-3662 | Outer Diameter 62 mm | In distribution |
| 174-3254 | Outer Diameter 54 mm | In distribution |
| 175-2854 | Lumen/Inner Diameter 28 mm | In distribution |
| 175-4056 | Lumen/Inner Diameter 40 mm | In distribution |
| 172-2850 | Outer Diameter 50 mm | In distribution |
| 175-4058 | Lumen/Inner Diameter 40 mm | In distribution |
| 175-3254 | Lumen/Inner Diameter 32 mm | 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 |
|---|---|
| K111936 | 2011-09-21 |
| K060577 | 2006-04-28 |
| K053587 | 2006-03-17 |
| K970675 | 1997-08-22 |
| K971426 | 1997-07-09 |
| K971435 | 1997-07-09 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ortho Development Corp. | 510(k) number | 2011-12-19 | Not classified | Device Design | Tip of hex-head screwdriver may break off during use in hip replacement procedure. | 37 units | 2012-08-27 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-01-11 | Not classified | Process design | Component of total hip arthroplasty may break during surgical procedure. | 7 units | 2011-11-04 |
| 2011-01-11 | Not classified | Process design | Component of total hip arthroplasty may break during surgical procedure. | 33 units | 2011-11-04 |
| 2011-01-11 | Not classified | Process design | Component of total hip arthroplasty may break during surgical procedure. | 7 units | 2011-11-04 |
| 2011-01-11 | Not classified | Process design | Component of total hip arthroplasty may break during surgical procedure. | 33 units | 2011-11-04 |
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.