Omnifit
132 Degree Cementless Hip Stem
10manufacturers in China registered for this device type
14catalogue numbers in this listing
3510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (2). 6 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | KWL |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K920231 |
| Record published | 2015-09-24 |
| Record revised | 2018-07-06 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6041-1140 | Size: 11 | In distribution |
| 6041-0525 | Taper Connection: C-TPR | In distribution |
| S-1645-HF01 | Size: 11 | In distribution |
| 6041-0830 | Size: 8 | In distribution |
| 6070-1140A | Size: 11 | In distribution |
| 6041-1240 | Size: 12 | In distribution |
| 6070-0730A | Neck Angle: 132.0 Degree | In distribution |
| 6041-1035 | Taper Connection: C-TPR | In distribution |
| 6041-0935 | Neck Length: 35.0 Millimeter | In distribution |
| 6041-0730 | Size: 7 | In distribution |
| 6041-0625 | Taper Connection: C-TPR | In distribution |
| 6070-0830A | Size: 8 | In distribution |
| 6070-0935A | Neck Angle: 132.0 Degree | In distribution |
| 6076-0730A | Neck Length: 30.0 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ustar II Knee System | United Orthopedic Corp. | 115 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 95 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 95 |
| Instrument | Howmedica Osteonics Corp | 94 |
| UHR | Howmedica Osteonics Corp | 75 |
| Austin Moore | Howmedica Osteonics Corp | 67 |
| B-P Total HIP System | Endotec, Inc. | 66 |
| CS2 Acetabular Cup System | Consensus Orthopedics, Inc. | 64 |
| DJO Surgical | Encore Medical, L.P. | 62 |
| Restoration | Howmedica Osteonics Corp | 56 |
| Optimom Modular Heads | Corin Limited | 49 |
| Corin Unipolar Modular Head | Corin Limited | 36 |
Showing 12 of 167. All products under Prosthesis, Hip, Hemi-, Femoral, Metal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071471 | 2007-09-10 |
| K014226 | 2002-01-25 |
| K992570 | 1999-09-01 |
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 |
|---|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | 510(k) number | 2008-11-13 | Not classified | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. | 322 total units – all types | 2010-01-20 |
Recalls
3 of these are 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 |
|---|---|---|---|---|---|
| 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 | |
| 2024-06-19 | Class II | Employee error | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm) | 18 units | |
| 2024-06-19 | Class II | Employee error | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm) | 18 units | |
| 2024-06-19 | Class II | Employee error | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm) | 12 units | |
| 2009-06-26 | Not classified | Nonconforming Material/Component | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by thi | 24 | 2010-07-27 |
| 2009-01-06 | Not classified | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker’s Internal Material Specification for tensile bond strength and crystallinity. | 1,628 total stems, all varieties. | 2012-06-25 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
| 2007-10-26 | Not classified | Process control | Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. | 360 total | 2010-01-27 |
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.