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Titan™

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Titan™ FDA UDI
Generic Name
General external orthopaedic fixation system implantation kit, reusable FDA UDI
Device Name
The Titan Modular Total Shoulder system is indicated for painful and/or disabled joints, fracture-dislocations, and other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable. The Glenoid 2.5 set includes keeled and pegged glenoid trials to evaluate the size and fit of the implants. Glenoid sizers are included to visualize the implant size and anticipate the amount of bone resections. Instruments are provided for assistance. FDA UDI
Model / Reference
TITANG1IMP FDA UDI
Description
The Titan Modular Total Shoulder system is indicated for painful and/or disabled joints, fracture-dislocations, and other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable. The Glenoid 2.5 set includes keeled and pegged glenoid trials to evaluate the size and fit of the implants. Glenoid sizers are included to visualize the implant size and anticipate the amount of bone resections. Instruments are provided for assistance. FDA UDI

Identifiers

Primary DI / UDI-DI
10381780237525 FDA UDI
510(k) Number
K142413 FDA UDI
FDA Product Code
KWS FDA UDI
HSD FDA UDI
GMDN Term
General external orthopaedic fixation system implantation kit, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
888.3690 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

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 6244a9e7-cd34-45c5-adad-35c2b2ab45e3 36 fields · synced Jun 8, 2026