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Sign in to claim this brandAston Medical
US
Last updated May 27, 2026
What Aston Medical makes
Aston Medical manufactures orthopedic implants for hip and shoulder arthroplasty, including acetabular shells, polyethylene acetabular liners, shoulder prosthesis stems, and reverse shoulder prostheses. Their product line includes uncoated and coated shoulder humeral stems, reverse shoulder prosthesis bodies and base plates, and specialized components like constrained polyethylene liners for hip replacements.
The company’s devices are classified as Class II under FDA regulations and are authorised through 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. These products are listed in the FDA’s regulatory databases and are intended for use in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Aston Medical manufacture?
Aston Medical specializes in orthopedic implants used in hip and shoulder arthroplasty. Their product line includes acetabular shells for hip replacements, polyethylene acetabular liners (both standard and constrained), shoulder prosthesis stems (both uncoated and coated), reverse shoulder prosthesis bodies and base plates, and specialized components like reverse shoulder prosthesis cups and screws. These devices are designed to replace damaged or diseased joints, improving mobility and quality of life for patients.
Where is Aston Medical based, and where are their devices primarily authorised for use?
Aston Medical is based in the United States. Their devices are authorised for use in the U.S. through the FDA’s regulatory pathways, specifically 510(k) clearances and the Unique Device Identification (UDI) system. This means their products meet the FDA’s requirements for safety and effectiveness as medical devices in the U.S. market.
Which regulatory registries or databases list Aston Medical’s devices?
Aston Medical’s devices are listed in the FDA’s regulatory databases, including the 510(k) clearance registry and the Unique Device Identification (UDI) system. These registries track devices that have undergone the necessary authorisation processes to ensure compliance with U.S. medical device regulations. The inclusion in these databases confirms the devices have met FDA requirements for market authorisation.
How are Aston Medical’s devices classified under FDA regulations?
Aston Medical’s devices are classified as Class II under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. Class II devices typically require pre-market notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device before they can be marketed in the U.S.
What does it mean that Aston Medical’s devices are authorised through the FDA’s UDI system?
The FDA’s Unique Device Identification (UDI) system assigns a unique product code to each distinct medical device to improve tracking, reduce medical errors, and enhance the safety of patients. When Aston Medical’s devices are authorised through the UDI system, it means each product variant—such as specific sizes, models, or configurations—has a unique identifier linked to its regulatory status. This helps healthcare providers, regulators, and manufacturers quickly access critical information about the device, including its authorisation history and safety data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- aston-medical.com
- —
- —
- [email protected]
- Phone
- +33477930004
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 576503098
Catalogue (112)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tregor® | 37051 | FDA UDI | Class II | Active |
| Duocentric® | 50022 | FDA UDI | Class II | Active |
| Tregor® | 37062 | FDA UDI | Class II | Active |
| Tregor® | 36509STER | FDA UDI | Class II | Active |
| Tregor® | 33473STER | FDA UDI | Class II | Active |
| Duocentric® | 50419 | FDA UDI | Class II | Active |
| Tregor® | 35664 | FDA UDI | Class II | Active |
| Duocentric® | 50439STER | FDA UDI | Class II | Active |
| Duocentric® | 50004 | FDA UDI | Class II | Active |
| Tregor® | 36503STER | FDA UDI | Class II | Active |
| Tregor® | 200097 | FDA UDI | Class II | Active |
| Duocentric® | 50431 | FDA UDI | Class II | Active |
| Tregor® | 37044 | FDA UDI | Class II | Active |
| Tregor® | 36510STER | FDA UDI | Class II | Active |
| Tregor® | 35125 | FDA UDI | Class II | Active |
| Tregor® | 36501STER | FDA UDI | Class II | Active |
| Tregor® | 200098 | FDA UDI | Class II | Active |
| Duocentric® | 50293-US | FDA UDI | Class II | Active |
| Duocentric® | 600020 | FDA UDI | Class II | Active |
| Tregor® | 37046 | FDA UDI | Class II | Active |
| Duocentric® | 43014STER | FDA UDI | Class II | Active |
| Duocentric® | 50379 | FDA UDI | Class II | Active |
| Duocentric® | 50397 | FDA UDI | Class II | Active |
| Duocentric® | 50263 | FDA UDI | Class II | Active |
| Tregor® | 200096 | FDA UDI | Class II | Active |
| Tregor® | 36513STER | FDA UDI | Class II | Active |
| Duocentric® | 50442STER | FDA UDI | Class II | Active |
| Tregor® | 33348 | FDA UDI | Class II | Active |
| Duocentric® | 50378 | FDA UDI | Class II | Active |
| Duocentric® | 50381 | FDA UDI | Class II | Active |
| Duocentric® | 43016STER | FDA UDI | Class II | Active |
| Duocentric® | 50005 | FDA UDI | Class II | Active |
| Tregor® | 33349 | FDA UDI | Class II | Active |
| Tregor® | 200094 | FDA UDI | Class II | Active |
| Tregor® | 37042 | FDA UDI | Class II | Active |
| Duocentric® | 50294-US | FDA UDI | Class II | Active |
| Duocentric® | 50396 | FDA UDI | Class II | Active |
| Tregor® | 37049 | FDA UDI | Class II | Active |
| Duocentric® | 50441STER | FDA UDI | Class II | Active |
| Tregor® | 34464 | FDA UDI | Class II | Active |
| Tregor® | 36505STER | FDA UDI | Class II | Active |
| Tregor® | 37043 | FDA UDI | Class II | Active |
| Tregor® | 36500STER | FDA UDI | Class II | Active |
| Tregor® | 200142 | FDA UDI | Class II | Active |
| Tregor® | 200093 | FDA UDI | Class II | Active |
| Tregor® | 33476STER | FDA UDI | Class II | Active |
| Duocentric® | 50026 | FDA UDI | Class II | Active |
| Tregor® | 36504STER | FDA UDI | Class II | Active |
| Tregor® | 37056 | FDA UDI | Class II | Active |
| Duocentric® | 50006 | FDA UDI | Class II | Active |
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