Alteon
Femoral Stem, Press-Fit, Standard Offset, Cementless, HA Coated, Collarless, Traditional Length, Size 15
14manufacturers in China registered for this device type
326catalogue numbers in this listing
8510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| 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 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | MEH |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K162732 |
| Record published | 2022-08-18 |
| Record revised | 2025-05-09 (version 4) |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 191-13-07 | SZ 7 | In distribution |
| 190-00-07 | Collarless | In distribution |
| 190-30-15 | Size 15 | In distribution |
| 190-00-15 | Size 15 | In distribution |
| 190-00-01 | Size 1 | In distribution |
| 190-31-10 | Size 10 | In distribution |
| 190-21-07 | Length 107mm | In distribution |
| 190-20-11 | Size 11 | In distribution |
| 190-21-07 | Size 7 | In distribution |
| 190-30-13 | Length 123mm | In distribution |
| 190-31-05 | Collared | In distribution |
| 190-11-11 | Length 135mm | In distribution |
| 190-31-07 | Collared | In distribution |
| 190-20-08 | Length 110mm | In distribution |
| 188-00-14 | Standard Offset | In distribution |
| 190-20-12 | Size 12 | In distribution |
| 190-10-11 | Length 135mm | In distribution |
| 190-00-05 | Collarless | In distribution |
| 190-20-04 | Size 4 | In distribution |
| 190-30-06 | Size 6 | In distribution |
| 190-11-04 | Collared | In distribution |
| 188-01-12 | Extended Offset | In distribution |
| 188-01-02 | Extended Offset | In distribution |
| 188-01-04 | Extended Offset | In distribution |
| 188-01-17 | Extended Offset | In distribution |
| 190-30-03 | Size 3 | In distribution |
| 188-11-06 | Extended Offset | In distribution |
| 190-01-14 | Size 14 | In distribution |
| 190-10-02 | Size 2 | In distribution |
| 190-31-14 | Length 126mm | In distribution |
| 190-20-15 | Size 15 | In distribution |
| 190-00-02 | Size 2 | In distribution |
| 188-01-01 | Extended Offset | In distribution |
| 190-10-15 | Size 15 | In distribution |
| 190-11-12 | Size 12 | In distribution |
| 190-20-11 | Collarless | In distribution |
| 190-11-12 | Collared | In distribution |
| 190-11-13 | Size 13 | In distribution |
| 190-21-09 | Size 9 | In distribution |
| 190-10-03 | Size 3 | In distribution |
| 188-10-09 | Standard Offset | In distribution |
| 191-13-10 | SZ 10 | In distribution |
| 188-11-17 | Extended Offset | In distribution |
| 190-20-09 | Collarless | In distribution |
| 188-11-02 | Extended Offset | In distribution |
| 191-13-09 | SZ 9 | In distribution |
| 190-30-12 | Collared | In distribution |
| 190-20-13 | Collarless | In distribution |
| 190-20-09 | Size 9 | In distribution |
| 190-31-06 | Length 104mm | In distribution |
| 190-00-10 | Length 130mm | In distribution |
| 190-11-10 | Size 10 | In distribution |
| 191-15-03 | SZ 3 | In distribution |
| 188-10-08 | Standard Offset | In distribution |
| 190-21-04 | Collarless | In distribution |
| 191-02-09 | SZ 9 | In distribution |
| 188-01-13 | Extended Offset | In distribution |
| 191-03-14 | SZ 14 | In distribution |
| 191-13-06 | SZ 6 | In distribution |
| 188-00-03 | Standard Offset | In distribution |
| 190-00-06 | Length 112mm | In distribution |
| 190-21-09 | Length 113mm | In distribution |
| 190-00-13 | Collarless | In distribution |
| 188-00-11 | Standard Offset | In distribution |
| 190-01-03 | Size 3 | In distribution |
| 190-10-08 | Size 8 | In distribution |
| SPI-038526 | SIZE 13 | In distribution |
| 188-11-14 | Extended Offset | In distribution |
| 190-20-06 | Length 104mm | In distribution |
| 190-00-08 | Size 8 | In distribution |
| 191-02-12 | SZ 12 | In distribution |
| 190-20-08 | Size 8 | In distribution |
| 190-00-09 | Collarless | In distribution |
| 188-10-04 | Standard Offset | In distribution |
| 190-31-09 | Collared | In distribution |
| 190-11-11 | Size 11 | In distribution |
| SPI-038516 | SIZE 6 | In distribution |
| 188-10-13 | Standard Offset | In distribution |
| 188-11-03 | Extended Offset | In distribution |
| 190-30-11 | Length 118mm | In distribution |
| 191-02-06 | SZ 6 | In distribution |
| 188-10-17 | Standard Offset | In distribution |
| 190-20-12 | Length 121mm | In distribution |
| 188-00-01 | Standard Offset | In distribution |
| 190-01-02 | Length 94mm | In distribution |
| 191-13-12 | SZ 12 | In distribution |
| 190-30-12 | Size 12 | In distribution |
| 190-31-12 | Size 12 | In distribution |
| 188-10-07 | Standard Offset | In distribution |
| 190-30-04 | Size 4 | In distribution |
| 190-01-15 | Size 15 | In distribution |
| SPI-038513 | SIZE 3 | In distribution |
| 190-11-13 | Length 144mm | In distribution |
| SPI-038518 | SIZE 8 | In distribution |
| 191-02-05 | SZ 5 | In distribution |
| 190-11-09 | Length 126mm | In distribution |
| 190-20-04 | Length 99mm | In distribution |
| 191-02-08 | SZ 8 | In distribution |
| 190-11-07 | Length 116mm | In distribution |
| 190-30-08 | Size 8 | In distribution |
| 190-00-08 | Length 121mm | In distribution |
| 188-10-05 | Size 5 | In distribution |
| 190-31-08 | Size 8 | In distribution |
| 190-01-07 | Size 7 | In distribution |
| 190-31-15 | Size 15 | In distribution |
| 190-30-07 | Size 7 | In distribution |
| 190-00-04 | Length 103mm | In distribution |
| 190-10-12 | Collared | In distribution |
| 188-01-08 | Extended Offset | In distribution |
| 190-10-06 | Size 6 | In distribution |
| 190-21-12 | Collarless | In distribution |
| 188-11-05 | Extended Offset | In distribution |
| 191-15-07 | SZ 7 | In distribution |
| 190-01-13 | Size 13 | In distribution |
| 190-11-07 | Size 7 | In distribution |
| 190-00-05 | Size 5 | In distribution |
| 190-10-09 | Size 9 | In distribution |
| 191-13-04 | SZ 4 | In distribution |
| 191-13-03 | SZ 3 | In distribution |
| 190-00-02 | Length 94mm | In distribution |
| 190-31-05 | Size 5 | In distribution |
| 190-21-13 | Length 123mm | In distribution |
| 190-00-03 | Size 3 | In distribution |
| 190-11-14 | Size 14 | In distribution |
| 190-11-03 | Size 3 | In distribution |
| 188-11-13 | Extended Offset | In distribution |
| 188-11-12 | Extended Offset | In distribution |
| 190-21-03 | Length 96mm | In distribution |
| 190-30-10 | Collared | In distribution |
| 190-01-08 | Size 8 | In distribution |
| 188-00-04 | Standard Offset | In distribution |
| 190-10-10 | Size 10 | In distribution |
| 188-11-09 | Extended Offset | In distribution |
| 190-10-09 | Length 126mm | In distribution |
| 191-13-15 | SZ 15 | In distribution |
| 190-10-13 | Length 144mm | In distribution |
| 190-31-07 | Size 7 | In distribution |
| 190-01-08 | Length 121mm | In distribution |
| 190-31-09 | Size 9 | In distribution |
| 188-00-07 | Standard Offset | In distribution |
| 190-00-01 | Collarless | In distribution |
| 190-01-04 | Size 4 | In distribution |
| 190-01-06 | Length 112mm | In distribution |
| 188-00-10 | Standard Offset | In distribution |
| 188-00-12 | Standard Offset | In distribution |
| 190-21-15 | Size 15 | In distribution |
| 190-31-13 | Collared | In distribution |
| SPI-038514 | SIZE 4 | In distribution |
| 188-10-02 | Standard Offset | In distribution |
| 188-11-16 | Extended Offset | In distribution |
| 190-00-04 | Size 4 | In distribution |
| 188-01-06 | Extended Offset | In distribution |
| 191-02-10 | SZ 10 | In distribution |
| 190-31-11 | Size 11 | In distribution |
| 190-01-11 | Collarless | In distribution |
| 190-00-11 | Size 11 | In distribution |
| 190-01-05 | Collarless | In distribution |
| 191-12-01 | SZ 1 | In distribution |
| 190-11-06 | Size 6 | In distribution |
| 190-21-10 | Collarless | In distribution |
| 188-10-14 | Standard Offset | In distribution |
| 191-02-03 | SZ 3 | In distribution |
| 190-01-10 | Length 130mm | In distribution |
| 190-31-03 | Collared | In distribution |
| 190-01-12 | Size 12 | In distribution |
| 190-11-10 | Collared | In distribution |
| 190-21-08 | Size 8 | In distribution |
| 190-30-09 | Length 113mm | In distribution |
| 188-10-11 | Standard Offset | In distribution |
| 190-31-11 | Collared | In distribution |
| 188-01-05 | Extended Offset | In distribution |
| 190-10-01 | Size 1 | In distribution |
| 190-21-06 | Size 6 | In distribution |
| 190-01-14 | Length 148mm | In distribution |
| SPI-043376 | In distribution | |
| 190-30-05 | Size 5 | In distribution |
| 191-13-11 | SZ 11 | In distribution |
| 190-10-07 | Length 116mm | In distribution |
| 188-10-16 | Standard Offset | In distribution |
| 190-20-06 | Size 6 | In distribution |
| 190-30-10 | Size 10 | In distribution |
| 190-01-09 | Size 9 | In distribution |
| 190-21-14 | Size 14 | In distribution |
| 190-21-08 | Collarless | In distribution |
| 190-11-03 | Length 98mm | In distribution |
| 190-00-11 | Collarless | In distribution |
| 190-21-04 | Size 4 | In distribution |
| 190-20-05 | Size 5 | In distribution |
| 190-21-13 | Size 13 | In distribution |
| 190-30-15 | Length 129mm | In distribution |
| 190-21-11 | Size 11 | In distribution |
| 190-10-02 | Collared | In distribution |
| 190-00-10 | Size 10 | In distribution |
| 190-01-15 | Collarless | In distribution |
| 190-01-04 | Length 103mm | In distribution |
| SPI-043375 | In distribution | |
| 190-10-01 | Length 94mm | In distribution |
| 190-01-02 | Size 2 | In distribution |
| 188-00-13 | Standard Offset | In distribution |
| 188-01-07 | Extended Offset | In distribution |
| 188-11-08 | Extended Offset | In distribution |
| 190-10-12 | Size 12 | In distribution |
| 188-11-07 | Extended Offset | In distribution |
| 190-00-14 | Size 14 | In distribution |
| 190-10-05 | Size 5 | In distribution |
| 190-20-14 | Size 14 | In distribution |
| 190-20-07 | Collarless | In distribution |
| 190-20-10 | Size 10 | In distribution |
| 188-00-16 | Standard Offset | In distribution |
| 188-00-05 | Standard Offset | In distribution |
| 190-10-14 | Collared | In distribution |
| 188-11-10 | Extended Offset | In distribution |
| 190-21-05 | Length 102mm | In distribution |
| 190-11-05 | Size 5 | In distribution |
| 190-11-09 | Size 9 | In distribution |
| SPI-038511 | SIZE 1 | In distribution |
| 190-00-09 | Size 9 | In distribution |
| 190-31-03 | Size 3 | In distribution |
| 191-13-14 | SZ 14 | In distribution |
| 190-31-06 | Size 6 | In distribution |
| 190-30-08 | Collared | In distribution |
| 190-10-10 | Collared | In distribution |
| 190-30-06 | Collared | In distribution |
| 190-11-05 | Length 107mm | In distribution |
| 190-21-05 | Size 5 | In distribution |
| 190-30-05 | Length 102mm | In distribution |
| 190-00-15 | Collarless | In distribution |
| 190-21-11 | Length 118mm | In distribution |
| 190-10-04 | Size 4 | In distribution |
| 190-00-12 | Size 12 | In distribution |
| 188-00-08 | Standard Offset | In distribution |
| 190-10-05 | Length 107mm | In distribution |
| 190-00-03 | Collarless | In distribution |
| 190-30-09 | Size 9 | In distribution |
| 190-10-06 | Collared | In distribution |
| 190-00-07 | Size 7 | In distribution |
| 190-30-14 | Size 14 | In distribution |
| 190-01-12 | Length 139mm | In distribution |
| 190-20-13 | Size 13 | In distribution |
| 190-21-03 | Size 3 | In distribution |
| 190-20-10 | Length 115mm | In distribution |
| 188-11-01 | Extended Offset | In distribution |
| 190-10-08 | Collared | In distribution |
| 188-00-06 | Standard Offset | In distribution |
| 190-01-03 | Collarless | In distribution |
| 190-01-07 | Collarless | In distribution |
| 190-01-05 | Size 5 | In distribution |
| 191-15-06 | SZ 6 | In distribution |
| 190-01-06 | Size 6 | In distribution |
| 190-31-14 | Size 14 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novation | Exactech, Inc. | 317 |
| Pinnacle | Depuy Orthopaedics, Inc. | 305 |
| SP-CL Hip Stem | Waldemar Link GmbH & Co. KG | 219 |
| Emperion | Smith & Nephew, Inc. | 201 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 154 |
| Instrument | Howmedica Osteonics Corp | 145 |
| Restoration | Howmedica Osteonics Corp | 144 |
| Mfinity Femoral System | Medacta International SA | 138 |
| Echelon | Smith & Nephew, Inc. | 134 |
| Trinity Acetabular Hip System | Corin Limited | 128 |
| Redapt | Smith & Nephew, Inc. | 127 |
| Esop® | Fournitures Hospitalieres Industrie | 120 |
Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243839 | 2025-03-10 |
| K162732 | 2017-04-26 |
| K153649 | 2016-08-31 |
| K113320 | 2012-03-16 |
| K080980 | 2008-05-06 |
| K040613 | 2004-06-04 |
| K000242 | 2000-02-16 |
| K990197 | 1999-02-04 |
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 |
|---|---|---|---|---|---|---|---|
| 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 |
Recalls
2 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. | 136 devices | |
| 2015-09-23 | Class II | Under Investigation by firm | Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating. | 8 | 2017-03-01 |
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.