Unitrax
Neck Adjustment Sleeve
10manufacturers in China registered for this device type
33catalogue 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) | K992570 |
| Record published | 2015-09-24 |
| Record revised | 2023-02-07 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 38 to 61 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6942-5-053 | Outer Diameter 53.0 mm | In distribution |
| 6942-5-046 | Outer Diameter 46.0 mm | In distribution |
| 6942-7-060 | Taper Connection: C-TPR | In distribution |
| 6942-6-050 | Taper Connection: 2¿52′ | In distribution |
| 6942-6-020 | Taper Connection: 2¿52′ | In distribution |
| 6942-5-052 | Outer Diameter 52.0 mm | In distribution |
| 6942-6-030 | Taper Connection: 2¿52′ | In distribution |
| 6942-5-047 | Outer Diameter 47.0 mm | In distribution |
| 6942-6-060 | Taper Connection: V40? | In distribution |
| 6942-5-041 | Outer Diameter 41.0 mm | In distribution |
| 6942-5-040 | Outer Diameter 40.0 mm | In distribution |
| 6942-5-045 | Outer Diameter 45.0 mm | In distribution |
| 6942-7-075 | Taper Connection: C-TPR | In distribution |
| 6942-5-049 | Outer Diameter 49.0 mm | In distribution |
| 6942-5-061 | Outer Diameter 61.0 mm | In distribution |
| 6942-5-056 | Outer Diameter 56.0 mm | In distribution |
| 6942-7-085 | Taper Connection: C-TPR | In distribution |
| 6942-7-065 | Taper Connection: C-TPR | In distribution |
| 6942-6-080 | Taper Connection: V40? | In distribution |
| 6942-5-058 | Outer Diameter 58.0 mm | In distribution |
| 6942-5-042 | Outer Diameter 42.0 mm | In distribution |
| 6942-5-050 | Outer Diameter 50.0 mm | In distribution |
| 6942-5-051 | Outer Diameter 51.0 mm | In distribution |
| 6942-5-038 | Outer Diameter 38.0 mm | In distribution |
| 6942-6-010 | Taper Connection: 2¿52′ | In distribution |
| 6942-6-070 | Taper Connection: V40? | In distribution |
| 6942-6-075 | Offset: 8.0 Millimeter | In distribution |
| 6942-5-044 | Outer Diameter 44.0 mm | In distribution |
| 6942-5-054 | Outer Diameter 54.0 mm | In distribution |
| 6942-5-055 | Outer Diameter 55.0 mm | In distribution |
| 6942-5-043 | Outer Diameter 43.0 mm | In distribution |
| 6942-5-048 | Outer Diameter 48.0 mm | In distribution |
| 6942-6-065 | Taper Connection: V40? | 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
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | UDI-DI | 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 |
| Howmedica Osteonics Corp | UDI-DI | 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 |
| Howmedica Osteonics Corp | UDI-DI | 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 |
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 |
|---|---|---|---|---|---|
| 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 | |
| 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.