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BIOMET SPAIN ORTHOPAEDICS SL

US

Last updated May 27, 2026

What BIOMET SPAIN ORTHOPAEDICS SL makes

The company manufactures tibial inserts for knee replacements, including constrained variants sized for medial, small, large, and extra-large applications.

These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) system. The manufacturer is based in 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 Biomét Spain Orthopaedics SL primarily manufacture?

Biomét Spain Orthopaedics SL specializes in manufacturing tibial inserts for knee replacement surgeries. These inserts are designed to fit within knee prostheses and include constrained variants tailored for different patient sizes, such as medial, small, large, and extra-large applications. The focus is on orthopaedic knee components.

Where is Biomét Spain Orthopaedics SL based?

The company is based in the United States. While the name includes 'Spain,' the operational headquarters and manufacturing are located in the US, as indicated by the country designation.

Which regulatory registries list the devices manufactured by Biomét Spain Orthopaedics SL?

The devices produced by Biomét Spain Orthopaedics SL are listed in the FDA’s Unique Device Identification (UDI) system. This registry ensures traceability and compliance tracking for Class II devices, which includes their tibial inserts for knee replacements.

How are the devices manufactured by Biomét Spain Orthopaedics SL classified under FDA regulations?

The tibial inserts produced by Biomét Spain Orthopaedics SL fall under Class II classification according to FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as manufacturing controls and performance standards.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
zimmerbiomet.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1(800)342-5454
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
460900553

Catalogue (25)

DeviceModel / ReferenceRegistriesClassStatus
Ps Constrained Insert Med 178862
FDA UDI
Class IIActive
Ps Constrained Insert Xsm 178822
FDA UDI
Class IIActive
Ps Constrained Insert Sml 178840
FDA UDI
Class IIActive
Ps Constrained Insert Xsm 178820
FDA UDI
Class IIActive
Ps Constrained Insert Lge 178885
FDA UDI
Class IIActive
Ps Constrained Insert Xlg 178900
FDA UDI
Class IIActive
Ps Constrained Insert Lge 178882
FDA UDI
Class IIActive
Ps Constrained Insert Xsm 178825
FDA UDI
Class IIActive
Ps Constrained Insert Xsm 178832
FDA UDI
Class IIActive
Ps Constrained Insert Med 178868
FDA UDI
Class IIActive
Ps Constrained Insert Lge 178880
FDA UDI
Class IIActive
Ps Constrained Insert Sml 178852
FDA UDI
Class IIActive
Ps Constrained Insert Sml 178842
FDA UDI
Class IIActive
Ps Constrained Insert Xlg 178905
FDA UDI
Class IIActive
Ps Constrained Insert Xlg 178902
FDA UDI
Class IIActive
Ps Constrained Insert Xlg 178912
FDA UDI
Class IIActive
Ps Constrained Insert Lge 178888
FDA UDI
Class IIActive
Ps Constrained Insert Sml 178848
FDA UDI
Class IIActive
Ps Constrained Insert Med 178872
FDA UDI
Class IIActive
Ps Constrained Insert Med 178860
FDA UDI
Class IIActive
Ps Constrained Insert Lge 178892
FDA UDI
Class IIActive
Ps Constrained Insert Sml 178845
FDA UDI
Class IIActive
Ps Constrained Insert Med 178865
FDA UDI
Class IIActive
Ps Constrained Insert Xlg 178908
FDA UDI
Class IIActive
Ps Constrained Insert Xsm 178828
FDA UDI
Class IIActive

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