Identity
- Trade Name
- Titan™ Total Shoulder System FDA UDI
- Generic Name
- Stem-fixed metallic humeral head prosthesis FDA UDI
- Device Name
- The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the polyethylene cemented glenoid bone. It is intended for optimal osteotomy coverage and soft tissue balancing. FDA UDI
- Model / Reference
- M9200104416E FDA UDI
- Description
- The Titan Modular Total Shoulder Humeral Head has an eccentric articulating surface. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the polyethylene cemented glenoid bone. It is intended for optimal osteotomy coverage and soft tissue balancing. FDA UDI
Identifiers
- Catalog Number
- MHH-0920-010-4416E FDA UDI
- Primary DI / UDI-DI
- 10381780120285 FDA UDI
- 510(k) Number
- K142413 FDA UDI
- FDA Product Code
- HSD FDA UDIKWS FDA UDI
- GMDN Term
- Stem-fixed metallic humeral head prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 FDA UDI888.3660 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: Stem-fixed metallic humeral head 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 Stem-fixed metallic humeral head prosthesis.
- MRS — Howmedica Osteonics Corp. · Class II
- FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
- FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC. · Class II
- FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
- PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- Equinoxe — Exactech, Inc. · Class II
- TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
Cleared under the same submission
K142413 also covers:
- Integra® — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 66a06c5d-5ca8-4685-aeb3-22c5f30056ff 38 fields · synced May 30, 2026