Question 1

What types of medical devices does Adler Ortho S.p.A manufacture?

Accepted Answer

Adler Ortho S.p.A specializes in orthopedic implants for joint reconstruction. Their portfolio includes modular femoral and tibial components like the CO-CR HEADS and APTA STEM, spinal fixation devices such as FOOT SCREWS, and customizable systems for knee and hip replacements, including the DREAM and OMNIA. They also produce modular acetabular components (e.g., PANTHEON PHR) and mobility-enhancing devices like the BIS MOBILITY system, all designed for hip arthroplasty.

Question 2

Where is Adler Ortho S.p.A based?

Accepted Answer

Adler Ortho S.p.A is headquartered in Italy, where it develops and manufactures its orthopedic implant products. The company’s location aligns with EU regulatory frameworks, ensuring compliance with local and regional medical device standards.

Question 3

Which regulatory registries list Adler Ortho S.p.A’s devices?

Accepted Answer

Adler Ortho S.p.A’s devices are registered in the eudamed database, the official EU portal for medical device information under the Medical Device Regulation (MDR). This registry ensures transparency and traceability of high-risk orthopedic implants, including those classified as Class IIb and Class III.

Question 4

How are Adler Ortho S.p.A’s devices classified under EU regulations?

Accepted Answer

Adler Ortho S.p.A’s devices are classified as Class IIb and Class III under EU medical device regulations. This classification reflects their higher-risk nature, particularly for orthopedic implants used in joint reconstruction and spinal fixation, requiring stricter compliance with safety, performance, and clinical evaluation requirements.

Device	Model / Reference	Registries	Class	Status
Genus	1189007	EUDAMED	Class III	Active
Genus	1138927	EUDAMED	Class III	Active
Genus	1138215	EUDAMED	Class III	Active
Apta Stem	0101605	EUDAMED	Class III	Active
Genus	1130207	EUDAMED	Class III	Active
Genus	1130224	EUDAMED	Class III	Active
Genus	1132206	EUDAMED	Class III	Active
A-Acuta	0105126	EUDAMED	Class III	Active
Apta Stem	0101208	EUDAMED	Class III	Active
Pantheon Phr	2800230	EUDAMED	Class III	Active
Apta Stem	0181215	EUDAMED	Class III	Active
Apta Stem	0101204	EUDAMED	Class III	Active
Duplex	0872154	EUDAMED	Class III	Active
Apta-Fix Stem	0181611	EUDAMED	Class III	Active
Far	2501106	EUDAMED	Class IIb	Active
Omnia	0763102	EUDAMED	Class III	Active
Antea	3300202	EUDAMED	Class IIb	Active
Apta-Fix Stem	0181708	EUDAMED	Class III	Active
Antea	3301102	EUDAMED	Class IIb	Active
Dream	0188910	EUDAMED	Class III	Active
Dream	0189806	EUDAMED	Class III	Active
Pantheon Phr	2800010	EUDAMED	Class III	Active
Apta-Fix Stem	0181714	EUDAMED	Class III	Active
Navicula	3400003	EUDAMED	Class IIb	Active
Antea	3301554	EUDAMED	Class IIb	Active
Duplex	0772254	EUDAMED	Class III	Active
Far	2500120	EUDAMED	Class IIb	Active
Apta-Fix Stem	0101513	EUDAMED	Class III	Active
Genus Uni	1851203	EUDAMED	Class III	Active
Parva- Parva Fix	0108210	EUDAMED	Class III	Active
Omnia	0761000	EUDAMED	Class III	Active
Omnia	0762860	EUDAMED	Class III	Active
Genus	1758027	EUDAMED	Class III	Active
Omnia	0760045	EUDAMED	Class III	Active
Apta Stem	0101711	EUDAMED	Class III	Active
Dream	0108907	EUDAMED	Class III	Active
Genus Uni	1851202	EUDAMED	Class III	Active
Far	2500130	EUDAMED	Class IIb	Active
Hydra-Fix	0106911	EUDAMED	Class III	Active
Pantheon Phr	2881408	EUDAMED	Class III	Active
Dream	0110003	EUDAMED	Class III	Active
Bis Mobility	0895101	EUDAMED	Class III	Active
Duplex	0771142	EUDAMED	Class III	Active
Dream	0110002	EUDAMED	Class III	Active
Duplex	0872166	EUDAMED	Class III	Active
Pantheon Phr	2801412	EUDAMED	Class III	Active
Duplex	0771962	EUDAMED	Class III	Active
Screw For Cup	0761130	EUDAMED	Class III	Active
Genus	1189014	EUDAMED	Class III	Active
Agilis	0700003	EUDAMED	Class III	Active

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