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
A-Aequa	0193122	EUDAMED	Class III	Active
Screw For Cup	0778140	EUDAMED	Class III	Active
Genus Uni	1710035	EUDAMED	Class IIb	Active
Dream	0110204	EUDAMED	Class III	Active
Antea	3301253	EUDAMED	Class IIb	Active
Co-Cr Heads	0524403	EUDAMED	Class III	Active
Apta Stem	0101616	EUDAMED	Class III	Active
Bis Mobility	0896033	EUDAMED	Class III	Active
Foot Screws	2200321	EUDAMED	Class IIb	Active
Dream	0106210	EUDAMED	Class III	Active
Bis Mobility	0896101	EUDAMED	Class III	Active
Pantheon Phr	2800610	EUDAMED	Class III	Active
Pantheon Phr	2800810	EUDAMED	Class III	Active
Omnia	0764148	EUDAMED	Class III	Active
Pantheon Phr	2800925	EUDAMED	Class III	Active
Apta-Fix Stem	0181617	EUDAMED	Class III	Active
Apta-Fix Stem	0181615	EUDAMED	Class III	Active
Pantheon Phr	2802105	EUDAMED	Class III	Active
Duplex	0872264	EUDAMED	Class III	Active
Agilis	0758142	EUDAMED	Class III	Active
Antea	3300204	EUDAMED	Class IIb	Active
Apta Stem	0101112	EUDAMED	Class III	Active
Foot Screws	2210336	EUDAMED	Class IIb	Active
Bis Mobility	0871201	EUDAMED	Class III	Active
Pantheon Phr	2800630	EUDAMED	Class III	Active
Antea	3100007	EUDAMED	Class IIb	Active
Apta Stem	0101104	EUDAMED	Class III	Active
Hydra-Fix	0106913	EUDAMED	Class III	Active
Hydra-Fix	0106808	EUDAMED	Class III	Active
Antea	3301152	EUDAMED	Class IIb	Active
Pantheon Phr	2801650	EUDAMED	Class III	Active
Apta-Fix Stem	0181613	EUDAMED	Class III	Active
Foot Screws	2200936	EUDAMED	Class IIb	Active
Apta Stem	0101706	EUDAMED	Class III	Active
Foot Screws	2210736	EUDAMED	Class IIb	Active
Bis Mobility	0871333	EUDAMED	Class III	Active
Modula Necks	0460330	EUDAMED	Class III	Active
Duplex	0771262	EUDAMED	Class III	Active
Omnia	0764177	EUDAMED	Class III	Active
Antea	3180005	EUDAMED	Class IIb	Active
Navicula	3400112	EUDAMED	Class IIb	Active
Duplex	0772252	EUDAMED	Class III	Active
Apta Stem	0181206	EUDAMED	Class III	Active
Foot Screws	2200730	EUDAMED	Class IIb	Active
Apta-Fix Stem	0101408	EUDAMED	Class III	Active
Foot Screws	2200524	EUDAMED	Class IIb	Active
Hydra-Fix	0106908	EUDAMED	Class III	Active
Omnia	0762864	EUDAMED	Class III	Active
Omnia	0763002	EUDAMED	Class III	Active
Antea	3301203	EUDAMED	Class IIb	Active

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