Prosthesis, Hip, Femoral, Resurfacing
36 catalogue numbers from 9510-26-000, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Femoral, Resurfacing. 1 manufacturer in China is registered for this product code.
1manufacturer
36catalogue numbers in this listing
1510(k) clearance
3recalls on this code
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 | Zimmer, Inc., United States |
|---|---|
| FDA product code | KXA |
| Device type | Prosthesis, Hip, Femoral, Resurfacing |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K950998 |
| Record published | 2016-07-20 |
| Record revised | 2020-06-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9510-26-000 | 26mm/Neutral 12/14 Taper | In distribution |
| 4510-00-042 | 42 mm | In distribution |
| 4510-00-051 | 51 mm | In distribution |
| 4510-00-055 | 55 mm | In distribution |
| 9510-22-004 | 22mm/-4 12/14 Taper | In distribution |
| 9510-26-800 | 26mm/+8 12/14 Taper | In distribution |
| 4510-00-049 | 49 mm | In distribution |
| 4510-00-039 | 39 mm | In distribution |
| 4510-00-046 | 46 mm | In distribution |
| 9510-00-001 | In distribution | |
| 4510-00-045 | 45 mm | In distribution |
| 4510-10-400 | +4 mm | In distribution |
| 4510-00-060 | 60 mm | In distribution |
| 4510-00-054 | 54 mm | In distribution |
| 9510-00-005 | In distribution | |
| 4510-00-048 | 48 mm | In distribution |
| 4510-00-053 | 53 mm | In distribution |
| 9510-26-004 | 26mm/-4 12/14 Taper | In distribution |
| 4510-00-038 | 38 mm | In distribution |
| 4510-00-058 | 58 mm | In distribution |
| 4510-00-043 | 43 mm | In distribution |
| 9510-22-400 | 22mm/+4 12/14 Taper | In distribution |
| 4510-00-056 | 56 mm | In distribution |
| 4510-10-800 | +8 mm | In distribution |
| 4510-00-044 | 44 mm | In distribution |
| 9510-26-400 | 26mm/+4 12/14 Taper | In distribution |
| 4510-10-004 | -4 mm | In distribution |
| 4510-00-040 | 40 mm | In distribution |
| 4510-00-047 | 47 mm | In distribution |
| 4510-00-041 | 41 mm | In distribution |
| 4510-00-052 | 52 mm | In distribution |
| 4510-10-000 | Neutral | In distribution |
| 4510-00-059 | 59 mm | In distribution |
| 9510-22-800 | 22mm/+8 12/14 Taper | In distribution |
| 4510-00-050 | 50 mm | In distribution |
| 4510-00-057 | 57 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 |
| Conserve® | Microport Orthopedics Inc. | 33 |
| B-P Total HIP System | Endotec, Inc. | 13 |
| 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 |
|---|---|
| K070292 | 2007-04-26 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-09-04 | Class II | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient | 209 | 2014-04-16 |
| 2007-09-26 | Not classified | Packaging process control | Mislabeled as to size; 54mm package contains 46 mm device and vice versa. | 1 | 2008-06-04 |
| 2007-09-26 | Not classified | Packaging process control | Mislabeled as to size; 54mm package contains 46 mm device and vice versa. | 5 | 2008-06-04 |
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.