Kyocera Medical Technologies, Inc.
The A 400 femoral stem is the thighbone component of a total hip replacement. The filed item identifies an extended lateral-offset stem with a reduced distal taper; these terms describe…
The A 400 femoral stem is the thighbone component of a total hip replacement. The filed item identifies an extended lateral-offset stem with a reduced distal taper; these terms describe this particular stem configuration within Kyocera’s A 400 system.
The stem sits in the femoral canal, and a separate femoral head attaches at its proximal taper to form the ball side of the joint. The head then articulates with a cup component, so this listing is for one implant component rather than a complete hip implant.
Listed Item
Reduced Distal Taper Femoral Stem, Extended Lateral Offset, 11.25mm
Configuration Within a 400
Kyocera lists the A 400 as a cementless hip system and offers stem variations such as reduced distal taper and different offsets. The offset option changes the stem geometry; it does not identify the head or cup included. The filed stem remains the specific extended-offset version named in its identity fields.
5manufacturers in China registered for this device type
260catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| 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 |
Record
| Listed by | Kyocera Medical Technologies, Inc., United States |
|---|---|
| FDA product code | OQI |
| Device type | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K112897 |
| Record published | 2015-10-28 |
| Record revised | 2020-09-09 (version 7) |
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, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
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| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
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| A 400 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
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| A 400 | In distribution | |
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| A 400 | In distribution | |
| A 400 | In distribution | |
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| A 450 | In distribution | |
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| A 450 | In distribution | |
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| A 400 | In distribution | |
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| A 450 | In distribution | |
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| A 400 | In distribution | |
| A 400 | In distribution | |
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| A 400 | In distribution | |
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| A 400 | In distribution | |
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| A 400 | In distribution | |
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| A 450 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
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| A 400 | In distribution | |
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| A 450 | In distribution | |
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| A 400 | In distribution | |
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| A 400 | In distribution | |
| A 400 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
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| A 400 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
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| A 400 | In distribution | |
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| A 400 | In distribution | |
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| A 400 | In distribution | |
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| A 400 | In distribution | |
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| A 400 | In distribution | |
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| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
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| A 450 | In distribution | |
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| A 400 | In distribution | |
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| A 400 | In distribution | |
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| A 450 | In distribution | |
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| A 400 | In distribution | |
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| A 400 | In distribution | |
| A 450 | In distribution | |
| A 400 | In distribution | |
| A 400 | In distribution | |
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| A 450 | In distribution | |
| A 400 | In distribution | |
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| A 400 | In distribution | |
| A 400 | In distribution |
Showing 250 of 260 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epore® XO | implantcast GmbH | 64 |
| G7® | Biomet Orthopedics | 50 |
| InSitu Hip System | Nextstep Arthropedix | 50 |
| G7 Acetabular Liner | Biomet Orthopedics | 47 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | implantcast GmbH | 40 |
| Novation | Exactech, Inc. | 37 |
| Trinity Acetabular Hip System with ECiMa Liners | Corin Limited | 28 |
| Procotyl® Prime | Microport Orthopedics Inc. | 25 |
| AcuMatch | Exactech, Inc. | 23 |
| Continuum® Trilogy® Allofit® | Zimmer, Inc. | 23 |
| G7® Longevity® | Zimmer, Inc. | 23 |
| Continuum® Trilogy® Allofit® Vivacit-E® | Zimmer, Inc. | 22 |
Showing 12 of 164. All products under Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
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.