Alteon
Alteon Short Tapered Wedge Stem, Standard Offset, Size 14
15manufacturers in China registered for this device type
151catalogue numbers in this listing
21510(k) clearances naming this product code
15recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (3), Zhejiang (2). 10 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 15. All 15 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | LZO |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K181532 |
| Record published | 2018-12-04 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Sizes | Length 195 to 295 mm; outer diameter 14 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-010-16-5295 | Length 295 mm | In distribution |
| 162-01-04 | 12/14 Taper | In distribution |
| 190-61-09 | Size 9 | In distribution |
| 190-60-07 | Size 7 | In distribution |
| 01-010-16-4195 | Outer Diameter 16 mm | In distribution |
| 01-010-26-5195 | Length 195 mm | In distribution |
| 01-010-16-4245 | Length 245 mm | In distribution |
| 162-00-07 | 12/14 Taper | In distribution |
| 188-30-03 | In distribution | |
| 188-30-14 | In distribution | |
| 01-010-19-4245 | Length 245 mm | In distribution |
| 188-30-06 | In distribution | |
| 01-010-15-4195 | Outer Diameter 15 mm | In distribution |
| 01-010-15-4245 | Length 245 mm | In distribution |
| 188-31-13 | In distribution | |
| 01-010-27-5245 | Outer Diameter 27 mm | In distribution |
| 01-010-20-5245 | Outer Diameter 20 mm | In distribution |
| 01-010-18-4195 | Outer Diameter 18 mm | In distribution |
| 191-03-06 | SZ 6 | In distribution |
| 188-31-11 | In distribution | |
| 190-61-05 | Size 5 | In distribution |
| 01-010-25-4245 | Outer Diameter 25 mm | In distribution |
| 01-010-24-5295 | Length 295 mm | In distribution |
| 01-010-19-5245 | Length 245 mm | In distribution |
| 188-30-05 | In distribution | |
| 01-010-30-5245 | Extended offset | In distribution |
| 162-00-04 | 12/14 Taper | In distribution |
| 01-010-23-5245 | Extended offset | In distribution |
| 01-010-25-4195 | Outer Diameter 25 mm | In distribution |
| 01-010-22-5195 | Length 195 mm | In distribution |
| 190-60-15 | Size 15 | In distribution |
| 01-010-25-4295 | Outer Diameter 25 mm | In distribution |
| 01-010-24-4295 | Standard Offset | In distribution |
| 01-010-18-4295 | Outer Diameter 18 mm | In distribution |
| 01-010-22-4295 | Outer Diameter 22 mm | In distribution |
| 01-010-14-4195 | Outer Diameter 14 mm | In distribution |
| 01-010-20-4295 | Outer Diameter 20 mm | In distribution |
| 188-31-05 | In distribution | |
| 01-010-22-4195 | Length 195 mm | In distribution |
| 01-010-19-4295 | Standard Offset | In distribution |
| 01-010-21-5295 | Outer Diameter 21 mm | In distribution |
| 188-30-04 | In distribution | |
| 190-61-15 | Size 15 | In distribution |
| 190-61-13 | Size 13 | In distribution |
| 188-31-01 | In distribution | |
| 188-30-07 | In distribution | |
| 162-01-03 | 12/14 Taper | In distribution |
| 01-010-20-4245 | Outer Diameter 20 mm | In distribution |
| 188-31-10 | In distribution | |
| 188-31-04 | In distribution | |
| 01-010-20-5295 | Length 295 mm | In distribution |
| 01-010-20-4195 | Outer Diameter 20 mm | In distribution |
| 191-03-03 | SZ 3 | In distribution |
| 01-010-29-4195 | Length 195 mm | In distribution |
| 01-010-17-5295 | Outer Diameter 17 mm | In distribution |
| 01-010-21-4295 | Standard Offset | In distribution |
| 188-30-09 | In distribution | |
| 162-00-05 | 12/14 Taper | In distribution |
| 01-010-18-5295 | Length 295 mm | In distribution |
| 01-010-18-5195 | Outer Diameter 18 mm | In distribution |
| 01-010-26-5245 | Extended offset | In distribution |
| 188-30-11 | In distribution | |
| 01-010-22-5295 | Length 295 mm | In distribution |
| 162-01-06 | 12/14 Taper | In distribution |
| 01-010-27-4295 | Outer Diameter 27 mm | In distribution |
| 01-010-21-4245 | Outer Diameter 21 mm | In distribution |
| 01-010-29-5195 | Outer Diameter 29 mm | In distribution |
| 01-010-19-5195 | Outer Diameter 19 mm | In distribution |
| 188-31-12 | In distribution | |
| 01-010-24-4245 | Standard offset | In distribution |
| 01-010-26-4295 | Standard Offset | In distribution |
| 01-010-17-5195 | Outer Diameter 17 mm | In distribution |
| 01-010-26-4245 | Length 245 mm | In distribution |
| 190-61-11 | Size 11 | In distribution |
| 188-30-13 | In distribution | |
| 188-30-10 | In distribution | |
| 190-61-07 | Size 7 | In distribution |
| 01-010-24-5195 | Length 195 mm | In distribution |
| 162-00-02 | 12/14 Taper | In distribution |
| 188-31-07 | In distribution | |
| 01-010-23-4245 | Standard offset | In distribution |
| 162-00-03 | 12/14 Taper | In distribution |
| 190-60-05 | Size 5 | In distribution |
| 188-31-17 | In distribution | |
| 01-010-28-4195 | Outer Diameter 28 mm | In distribution |
| 01-010-25-5245 | Length 245 mm | In distribution |
| 01-010-23-5195 | Length 195 mm | In distribution |
| 191-02-01 | SZ 1 | In distribution |
| 188-31-08 | In distribution | |
| 188-31-03 | In distribution | |
| 188-31-02 | In distribution | |
| 01-010-30-4245 | Length 245 mm | In distribution |
| 01-010-26-5295 | Length 295 mm | In distribution |
| 01-010-27-4195 | Outer Diameter 27 mm | In distribution |
| 01-010-22-5245 | Extended offset | In distribution |
| 01-010-17-5245 | Length 245 mm | In distribution |
| 162-01-02 | 12/14 Taper | In distribution |
| 01-010-16-5245 | Length 245 mm | In distribution |
| 01-010-17-4295 | Standard Offset | In distribution |
| 01-010-21-5245 | Outer Diameter 21 mm | In distribution |
| 01-010-23-4195 | Length 195 mm | In distribution |
| 188-31-09 | In distribution | |
| 188-30-17 | In distribution | |
| 188-30-16 | In distribution | |
| 01-010-22-4245 | Standard offset | In distribution |
| 01-010-20-5195 | Length 195 mm | In distribution |
| 01-010-23-5295 | Outer Diameter 23 mm | In distribution |
| 01-010-18-4245 | Length 245 mm | In distribution |
| 01-010-17-4245 | Length 245 mm | In distribution |
| 01-010-30-5195 | Length 195 mm | In distribution |
| 162-01-07 | 12/14 Taper | In distribution |
| 01-010-27-5195 | Outer Diameter 27 mm | In distribution |
| 188-30-15 | In distribution | |
| 01-010-29-5245 | Length 245 mm | In distribution |
| 188-30-02 | In distribution | |
| 01-010-28-4245 | Length 245 mm | In distribution |
| 01-010-25-5195 | Extended Offset | In distribution |
| 188-30-01 | In distribution | |
| 01-010-16-4295 | Outer Diameter 16 mm | In distribution |
| 191-03-08 | SZ 8 | In distribution |
| 188-31-15 | In distribution | |
| 01-010-17-4195 | Outer Diameter 17 mm | In distribution |
| 01-010-16-5195 | Outer Diameter 16 mm | In distribution |
| 01-010-25-5295 | Outer Diameter 25 mm | In distribution |
| 01-010-28-5195 | Length 195 mm | In distribution |
| 01-010-18-5245 | Length 245 mm | In distribution |
| 190-60-13 | Size 13 | In distribution |
| 01-010-27-4245 | Outer Diameter 27 mm | In distribution |
| 191-03-12 | SZ 12 | In distribution |
| 01-010-23-4295 | Standard Offset | In distribution |
| 188-31-06 | In distribution | |
| 01-010-24-4195 | Length 195 mm | In distribution |
| 162-01-05 | 12/14 Taper | In distribution |
| 162-00-06 | 12/14 Taper | In distribution |
| 01-010-21-4195 | Length 195 mm | In distribution |
| 190-60-09 | Size 9 | In distribution |
| 01-010-21-5195 | Length 195 mm | In distribution |
| 01-010-28-5245 | Extended offset | In distribution |
| 01-010-29-4245 | Outer Diameter 29 mm | In distribution |
| 190-60-11 | Size 11 | In distribution |
| 188-31-16 | In distribution | |
| 01-010-30-4195 | Length 195 mm | In distribution |
| 01-010-14-4245 | Length 245 mm | In distribution |
| 01-010-19-4195 | Outer Diameter 19 mm | In distribution |
| 01-010-24-5245 | Extended offset | In distribution |
| 01-010-19-5295 | Outer Diameter 19 mm | In distribution |
| 188-30-12 | In distribution | |
| 01-010-15-4295 | Standard Offset | In distribution |
| 188-30-08 | In distribution | |
| 01-010-26-4195 | Length 195 mm | In distribution |
| 191-03-13 | SZ 13 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Libertas | Maxx Orthopedics Inc. | 1,832 |
| Redapt | Smith & Nephew, Inc. | 326 |
| Bencox Hip System | Corentec Co., Ltd. | 295 |
| M-Vizion Femoral Revision System | Medacta International SA | 289 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Zimmer, Inc. | 280 |
| Profemur® | Microport Orthopedics Inc. | 229 |
| DJO Surgical | Encore Medical, L.P. | 162 |
| Instrument | Howmedica Osteonics Corp | 152 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Exactech, Inc. | 136 |
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 136 |
| Wagner SL Revision® | Zimmer, Inc. | 133 |
| RingLoc® Hip System | Biomet Orthopedics | 130 |
Showing 12 of 691. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221323 | 2023-05-19 |
| K190890 | 2019-10-22 |
| K182462 | 2018-11-08 |
| K181532 | 2018-09-04 |
| K150066 | 2015-07-20 |
| K141821 | 2014-08-28 |
| K140674 | 2014-06-30 |
| K121392 | 2013-01-16 |
| K103012 | 2010-11-10 |
| K102487 | 2010-11-08 |
| K083392 | 2008-12-17 |
| K070479 | 2007-03-15 |
| K063279 | 2006-11-29 |
| K060107 | 2006-02-06 |
| K052787 | 2005-12-27 |
| K051858 | 2005-12-01 |
| K050398 | 2005-11-18 |
| K051682 | 2005-07-19 |
| K042842 | 2004-11-09 |
| K931617 | 1994-06-14 |
| K914574 | 1992-01-13 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Exactech, Inc. | 510(k) number | 2017-10-09 | Class II | Error in labeling | Wrong device description of the label identifying the implant | 34 | 2019-08-06 |
| Exactech, Inc. | 510(k) number | 2016-11-07 | Class II | Under Investigation by firm | Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. | 98 | 2019-08-05 |
Recalls
14 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 |
|---|---|---|---|---|---|
| 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 58158 devices | |
| 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 17929 units | |
| 2021-06-29 | Class II | Under Investigation by firm | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5). | 29 devices | |
| 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| 2021-06-29 | Class II | Under Investigation by firm | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5). | 30 devices | |
| 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| 2016-05-26 | Class II | Under Investigation by firm | Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another. | 14 | 2019-07-26 |
| 2016-05-26 | Class II | Under Investigation by firm | Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another. | 8 units | 2019-07-26 |
| 2014-03-07 | Class II | Component design/selection | The femoral stem is lacking specified plasma coating. | 10 | 2014-08-04 |
| 2012-11-05 | Class II | Labeling mix-ups | Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed | 26 Units | 2013-12-24 |
| 2012-11-05 | Class II | Labeling mix-ups | Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed | 26 Units | 2013-12-24 |
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.