Data / Medical devices / Italy / Adler Ortho S.P.A.

Adler Ortho S.P.A.: FDA-registered device maker in Cormano Milano, Italy, 1 510(k) clearance

Name: Adler Ortho S.P.A. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Adler Ortho S.P.A. is registered with the FDA (registration 3008281151) in Cormano Milano, Italy. It lists 12 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 13, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008281151
Address: Via Dell'Innovazione 9, Cormano Milano, Italy, 20032
Owner or operator: Adler Ortho S.p.A. (10086224)
Roles: Contract manufacturer, Manufacturer
First device listed: October 24, 2022
Registered through: 2026
Brand names listed: CUSTOM MADE FEMORAL PROSTHESIS, POROUS & UNCEMENTED, CUSTOM MADE HIP PROSTHESIS, CEMENTED, CUSTOM MADE HIP PROSTHESIS, CEMENTED, ADDITIVE, CUSTOM MADE HIP PROSTHESIS, UNCEMENTED, CUSTOM MADE HIP PROSTHESIS, UNCEMENTED, HA COATED, CUSTOM MADE KNEE JOINT PROSTHESIS, UNCEMENTED, CUSTOM MADE UPPER FEMORAL PROSTHESIS, Custom Made Device Instruments and more

Devices it lists

Device	Product code	Class	Role	Source
Dispenser, Cement	KIH	1	Manufacturer	accessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	OQH	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	MBL	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	KRO	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Upper Femoral	JDD	2	Manufacturer	accessdata.fda.gov
Reamer	HTO	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 13, 2025	K241059	Pantheon Proximal Femur Reconstruction (PFR) System	LPH	Substantially Equivalent	Adler Ortho S.P.A	accessdata.fda.gov

Compare with other makers

Updated January 13, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.