Biocore9 Femoral Resurfacing Component
Biocore9 Femoral Resurfacing Head replaces the articular surface of the existing femoral head for hip hemiarthroplasty. It is a cemented, nonconstrained implant that requires sufficient…
Biocore9 Femoral Resurfacing Head replaces the articular surface of the existing femoral head for hip hemiarthroplasty. It is a cemented, nonconstrained implant that requires sufficient femoral head and neck bone stock for stabilization.
The component has a thin, truncated spherical shell and a tapered central alignment stem. Its titanium-alloy structure carries a thin titanium-nitride ceramic coating.
Listed Item
Biocore9 Femoral Resurfacing Head Component 45.5 mm
Internal Surface and Sizes
The shell’s internal surface has a porous coating of titanium beads, while the alignment stem is not porous-coated. Available outside diameters range from 39.5 to 52.5 mm. The listed 45.5 mm resurfacing head is one size within this component family.
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 | BIOCORE9 LLC, United States |
|---|---|
| FDA product code | KXA |
| Device type | Prosthesis, Hip, Femoral, Resurfacing |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3400 |
| Establishment | Manufacturer |
| 510(k) | K201219 |
| Record published | 2021-09-27 |
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, manufacturing date |
| Storage | Handling environment temperature 5 to 40 °C; Storage environment temperature 5 to 40 °C |
| Sizes | Outer diameter 39.5 to 52.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Femoral Resurfacing Component – 41 mm | Outer Diameter 41 mm | In distribution |
| Femoral Resurfacing Component – 45.5 mm | Outer Diameter 45.5 mm | In distribution |
| Femoral Resurfacing Component – 39.5 mm | Outer Diameter 39.5 mm | In distribution |
| Femoral Resurfacing Component – 42.5 mm | Outer Diameter 42.5 mm | In distribution |
| Femoral Resurfacing Component – 44 mm | Outer Diameter 44 mm | In distribution |
| Femoral Resurfacing Component – 49 mm | Outer Diameter 49 mm | In distribution |
| Femoral Resurfacing Component – 51 mm | Outer Diameter 51 mm | In distribution |
| Femoral Resurfacing Component – 52.5 mm | Outer Diameter 52.5 mm | In distribution |
| Femoral Resurfacing Component – 47 mm | Outer Diameter 47 mm | In distribution |
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 |
| B-P Total HIP System | Endotec, Inc. | 13 |
| Synovo HIP Components | Synovo Production | 11 |
| Duramer® | Microport Orthopedics Inc. | 10 |
| 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 |
|---|---|
| K201219 | 2021-01-19 |
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.