Omnifit
10 Degree Series I Insert
4manufacturers in China registered for this device type
29catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | JDL |
| Device type | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) |
| Device class | Class 3 |
| Regulation | 21 CFR 888.3320 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K850352 |
| Record published | 2015-09-24 |
| Record revised | 2026-07-24 (version 5) |
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 |
| Sizes | Lumen/inner diameter 22 to 32 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2001-2846 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2001-2261 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2001-2650 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2001-2248 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2006-2656 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2006-2261 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2006-2652 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2006-2661 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2006-2256 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2006-2852 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2001-2848 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2006-3252 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 2001-3254 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 2006-2848 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2001-2644 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2001-2661 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2001-2648 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2001-2254 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2006-3261 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 2001-2246 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2001-2658 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2001-2856 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2001-2252 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2006-2856 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2001-2256 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2006-3256 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 2001-2244 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2001-2242 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2001-2646 | Lumen/Inner Diameter 26.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Consensus® Hip System | Consensus Orthopedics, Inc. | 57 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 57 |
| Conserve® | Microport Orthopedics Inc. | 20 |
| Fitmore® Hip Stem | Zimmer, Inc. | 19 |
| Dynasty | Microport Orthopedics Inc. | 12 |
| Healey HIP System | Biomet Orthopedics | 12 |
| Transcend® | Microport Orthopedics Inc. | 6 |
| CLS® Brevius® Kinectiv® | Zimmer, Inc. | 6 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 6 |
| Duracon | Howmedica Osteonics Corp | 5 |
| Kinectiv® | Zimmer, Inc. | 3 |
| CLS® Brevius™ Stem | Zimmer, Inc. | 2 |
Showing 12 of 20. All products under Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
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 |
|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | 510(k) number | 2026-07-30 | Not classified | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to | 12,156 US |
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 |
|---|---|---|---|---|---|
| 2004-01-09 | Not classified | Other | This device is not approved for sale in the US. | 3 (1 unit in US) | 2004-03-08 |
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.