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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
Press-fit shoulder humeral stem prosthesis FDA UDI
Device Name
The Titan Modular Total Shoulder press fit stem is shaped to provide proximal fixation. This stem has 1 mm incremental stem diameters located on it, along with 12 splines to contribute to an enhanced press fit and anti-rotation. FDA UDI
Model / Reference
SEM092002516 FDA UDI
Description
The Titan Modular Total Shoulder press fit stem is shaped to provide proximal fixation. This stem has 1 mm incremental stem diameters located on it, along with 12 splines to contribute to an enhanced press fit and anti-rotation. FDA UDI

Identifiers

Catalog Number
STEM-0920-025-16 FDA UDI
Primary DI / UDI-DI
10381780120599 FDA UDI
510(k) Number
K142413 FDA UDI
FDA Product Code
HSD FDA UDI
KWS FDA UDI
GMDN Term
Press-fit shoulder humeral stem prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3690 FDA UDI
888.3660 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: Press-fit shoulder humeral stem prosthesis

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 Press-fit shoulder humeral stem prosthesis.

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 5b1ada14-de2d-4ebc-8dd2-617ae565915a 38 fields · synced Jun 8, 2026