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
Apta-Fix Stem	0101514	EUDAMED	Class III	Active
Omnia	0765566	EUDAMED	Class III	Active
Apta Stem	0101707	EUDAMED	Class III	Active
A-Aequa	0193114	EUDAMED	Class III	Active
Dream	0108911	EUDAMED	Class III	Active
Antea	3300006	EUDAMED	Class IIb	Active
Navicula	3400002	EUDAMED	Class IIb	Active
Foot Screws	2200440	EUDAMED	Class IIb	Active
Apta-Fix Stem	0101813	EUDAMED	Class III	Active
Antea	3200103	EUDAMED	Class IIb	Active
Antea	3301105	EUDAMED	Class IIb	Active
Dream	0189811	EUDAMED	Class III	Active
Foot Screws	2210524	EUDAMED	Class IIb	Active
Far	2501105	EUDAMED	Class IIb	Active
Antea	3100225	EUDAMED	Class IIb	Active
Apta-Fix Stem	0101812	EUDAMED	Class III	Active
Apta-Fix Stem	0101411	EUDAMED	Class III	Active
Apta-Fix Stem	0101814	EUDAMED	Class III	Active
Screw For Cup	0778035	EUDAMED	Class III	Active
Bis Mobility	0895005	EUDAMED	Class III	Active
Dream	0188901	EUDAMED	Class III	Active
Duplex	0771950	EUDAMED	Class III	Active
Bis Mobility	0896505	EUDAMED	Class III	Active
Pantheon Phr	2801210	EUDAMED	Class III	Active
Antea	3100245	EUDAMED	Class IIb	Active
Apta Stem	0101205	EUDAMED	Class III	Active
Antea	3100012	EUDAMED	Class IIb	Active
Antea	3301201	EUDAMED	Class IIb	Active
Antea	3100015	EUDAMED	Class IIb	Active
Dream	0108903	EUDAMED	Class III	Active
Antea	3301204	EUDAMED	Class IIb	Active
Dream	0189503	EUDAMED	Class III	Active
Apta-Fix Stem	0101415	EUDAMED	Class III	Active
Bis Mobility	0896631	EUDAMED	Class III	Active
Pulchra	0109101	EUDAMED	Class III	Active
Navicula	3400001	EUDAMED	Class IIb	Active
Omnia	0763003	EUDAMED	Class III	Active
Foot Screws	2200421	EUDAMED	Class IIb	Active
Dream	0189804	EUDAMED	Class III	Active
Dream	0110210	EUDAMED	Class III	Active
Duplex	0771844	EUDAMED	Class III	Active
Far	2501307	EUDAMED	Class IIb	Active
Modula Necks	0460110	EUDAMED	Class III	Active
Foot Screws	2306535	EUDAMED	Class IIb	Active
Foot Screws	2306525	EUDAMED	Class IIb	Active
Navicula	3400101	EUDAMED	Class IIb	Active
Antea	3301556	EUDAMED	Class IIb	Active
Genus Uni	1851106	EUDAMED	Class III	Active
Genus Uni	1115015	EUDAMED	Class III	Active
Pantheon Phr	2800220	EUDAMED	Class III	Active

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