B-P Total HIP System
B-P HIP Femoral Resurfacing CUP W/Biocoat & W/Ultracoat - 32.5 MM
1manufacturer
13catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Endotec, Inc., United States |
|---|---|
| FDA product code | KXA |
| Device type | Prosthesis, Hip, Femoral, Resurfacing |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3400 |
| 510(k) | K904870 |
| Record published | 2015-09-17 |
| Record revised | 2024-04-17 (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 |
| Storage | Storage environment temperature 5 to 40 °C; Handling environment temperature 5 to 40 °C |
| Sizes | Outer diameter 32.5 to 52.5 mm |
| Distribution end date | 2024-03-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-03-0036 | Outer Diameter 36.5 mm | In distribution |
| 01-03-0038 | Outer Diameter 38 mm | Withdrawn |
| 01-03-0044 | Outer Diameter 44 mm | Withdrawn |
| 01-03-0047 | Outer Diameter 47 mm | Withdrawn |
| 01-03-0041 | Outer Diameter 41 mm | Withdrawn |
| 01-03-0032 | Outer Diameter 32.5 mm | Withdrawn |
| 01-03-0051 | Outer Diameter 51 mm | Withdrawn |
| 01-03-0049 | Outer Diameter 49 mm | Withdrawn |
| 01-03-0039 | Outer Diameter 39.5 mm | Withdrawn |
| 01-03-0034 | Outer Diameter 34.5 mm | Withdrawn |
| 01-03-0045 | Outer Diameter 45.5 mm | Withdrawn |
| 01-03-0052 | Outer Diameter 52.5 mm | Withdrawn |
| 01-03-0042 | Outer Diameter 42.5 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis | Corin Limited | 150 |
| Recap HIP System | Biomet Orthopedics | 57 |
| Prosthesis, Hip, Femoral, Resurfacing | Zimmer, Inc. | 36 |
| Conserve® | Microport Orthopedics Inc. | 33 |
| Synovo HIP Components | Synovo Production | 11 |
| Duramer® | Microport Orthopedics Inc. | 10 |
| Biocore9 Femoral Resurfacing Component | BIOCORE9 LLC | 9 |
| HemiCAP® | Arthrosurface, Inc. | 8 |
| Tara Femoral Component 43 | Biopro, Inc. | 1 |
| Tara Femoral Component 41 | Biopro, Inc. | 1 |
| Tara Femoral Component 38 | Biopro, Inc. | 1 |
| Tara Femoral Component 47 | Biopro, Inc. | 1 |
Showing 12 of 16. All products under Prosthesis, Hip, Femoral, Resurfacing
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K904870 | 1991-05-23 |
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.