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Titan™ Total Shoulder System

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Titan™ Total Shoulder System FDA UDI
Generic Name
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
Device Name
The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal bodies, humeral stems, and humeral heads in the TITAN™ Modular Total Shoulder System for total replacement Arthroplasty and provide stable fixation, proximal bone loading, and proper head placement. The glenoid component is intended for use of correction of humeral joint due to severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. The component is also used in repairing fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory as well as other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component). FDA UDI
Model / Reference
GLN092003003K FDA UDI
Description
The Titan Modular Total Shoulder System Keeled Glenoid is used in conjunction with metaphyseal bodies, humeral stems, and humeral heads in the TITAN™ Modular Total Shoulder System for total replacement Arthroplasty and provide stable fixation, proximal bone loading, and proper head placement. The glenoid component is intended for use of correction of humeral joint due to severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. The component is also used in repairing fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory as well as other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component). FDA UDI

Identifiers

Catalog Number
GLN092003003K FDA UDI
Primary DI / UDI-DI
10381780120216 FDA UDI
510(k) Number
K142413 FDA UDI
FDA Product Code
KWS FDA UDI
HSD FDA UDI
GMDN Term
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
888.3690 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Shoulder glenoid fossa prosthesis, prefabricated

Titan™ Total Shoulder System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Shoulder glenoid fossa prosthesis, prefabricated.

Cleared under the same submission

K142413 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 01ca5259-9800-45fb-82ba-426f9a7d2a47 38 fields · synced May 31, 2026