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Sign in to claim this brandADLER ORTHO SPA
US
Last updated May 23, 2026
What ADLER ORTHO SPA makes
The company manufactures orthopaedic instruments and components for hip revision surgeries, including uncoated femoral and tibial extension sleeves, reusable bone-resection reamers, and trial acetabular and femoral prostheses. Their portfolio also includes reusable joint prosthesis implantation kits, non-constrained polyethylene acetabular liners, and cross-linked polyethylene inserts for hip replacements.
These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from 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 Adler Ortho SPA manufacture?
Adler Ortho SPA specializes in orthopaedic devices primarily used in hip revision surgeries. Their portfolio includes uncoated femoral and tibial extension sleeves, reusable bone-resection orthopaedic reamers, trial acetabular and femoral prostheses, reusable joint prosthesis implantation kits, non-constrained polyethylene acetabular liners, and cross-linked polyethylene inserts. These devices are designed to assist surgeons during complex hip replacement procedures.
Where is Adler Ortho SPA based?
Adler Ortho SPA is based in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and distribution of its orthopaedic devices.
Which regulatory registries list Adler Ortho SPA’s devices?
Adler Ortho SPA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify device details, such as manufacturer information and classification.
How are Adler Ortho SPA’s devices classified under FDA regulations?
Adler Ortho SPA’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with.
What is the purpose of the reusable orthopaedic instruments and components produced by Adler Ortho SPA?
The reusable instruments and components, such as bone-resection reamers, trial prostheses, and implantation kits, are designed to streamline hip revision surgeries by providing precision tools for preparing bone surfaces, testing prosthesis fit, and facilitating the implantation process. Reusability helps reduce surgical waste and may contribute to cost efficiency in operating rooms.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 338847291
Catalogue (319)
Page 1 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pressurizer | Pressurizer | FDA UDI | Class I | Active |
| Pantheon System | Salvage Stem (Uncemented) | FDA UDI | Class II | Active |
| Impactor | Impactor | FDA UDI | Class I | Active |
| Pantheon PFR System | Salvage Plate with Spikes | FDA UDI | Class II | Active |
| Pantheon PFR System | Proximal Body | FDA UDI | Class II | Active |
| Cross-Linked PE Insert | Acetabular Insert | FDA UDI | Class II | Active |
| Cross-Linked PE Insert | Acetabular Insert | FDA UDI | Class II | Active |
| Handle | Handle | FDA UDI | Class I | Active |
| Pantheon System | Salvage Stem (Uncemented) | FDA UDI | Class II | Active |
| Pantheon System | Bridging Collar | FDA UDI | Class II | Active |
| Pantheon System | Bridging Collar | FDA UDI | Class II | Active |
| Extractor | Extractor | FDA UDI | Class I | Active |
| Pantheon System | Salvage Stem (Uncemented) | FDA UDI | Class II | Active |
| Collar Reamer | Reamer | FDA UDI | Class II | Active |
| Pantheon System | Bridging Collar | FDA UDI | Class II | Active |
| Container | Container | FDA UDI | Class I | Active |
| Delta Alumina Ceramic Heads Morse Taper 12/14 | Femoral Head | FDA UDI | Class II | Active |
| Pantheon System | Bridging Collar | FDA UDI | Class II | Active |
| Pantheon System | Bridging Collar | FDA UDI | Class II | Active |
| Positioner | Positioner | FDA UDI | Class I | Active |
| Handle | Handle | FDA UDI | Class I | Active |
| Reamer | Reamer | FDA UDI | Class I | Active |
| CoCrMo Alloy Femoral Heads 12/14 | Femoral Head | EUDAMEDFDA UDI | Class II | Active |
| Impactor | Impactor | FDA UDI | Class I | Active |
| Collar Reamer | Reamer | FDA UDI | Class II | Active |
| Pantheon PFR System | Proximal Body | FDA UDI | Class II | Active |
| Pantheon System | Bridging Collar | FDA UDI | Class II | Active |
| Cross-Linked PE Insert | Acetabular Insert | FDA UDI | Class II | Active |
| Prosthesis Trial | Prosthesis Trial | FDA UDI | Class I | Active |
| Pantheon System | Cylindrical Bridging Collar | FDA UDI | Class II | Active |
| Pantheon System | Salvage Stem (Cemented) | FDA UDI | Class II | Active |
| Reamer | Reamer | FDA UDI | Class I | Active |
| Trial shaft | Trial shaft | FDA UDI | Class I | Active |
| Instrument kit | Instrument kit | FDA UDI | N/A | Active |
| Trial Insert | Trial Insert | FDA UDI | Class I | Active |
| Screwdriver | Screwdriver | FDA UDI | Class I | Active |
| Reamer | Reamer | FDA UDI | Class I | Active |
| Reamer | Reamer | FDA UDI | Class I | Active |
| Trial Insert | Trial Insert | FDA UDI | Class I | Active |
| Trail Head | Trial Head | FDA UDI | Class I | Active |
| Trail Head | Trial Head | FDA UDI | Class I | Active |
| CoCrMo Alloy Femoral Heads 12/14 | Femoral Head | EUDAMEDFDA UDI | Class II | Active |
| Trial Cup | Trial Cup | FDA UDI | Class I | Active |
| Collar Reamer | Reamer | FDA UDI | Class II | Active |
| Trial Insert | Trial Insert | FDA UDI | Class I | Active |
| Container | Container | FDA UDI | Class I | Active |
| Acetabular Reamer | Acetabular Reamer | FDA UDI | Class I | Active |
| Cross-Linked PE Insert | Acetabular Insert | FDA UDI | Class II | Active |
| Pantheon System | Salvage Stem (Cemented) | FDA UDI | Class II | Active |
| FIXA Ti-Por® | Acetabular Shell | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Adler Ortho SpA Mezzolombardo Trento · IT FEI 3036773273