Identity
- Trade Name
- Titan™ Total Shoulder System FDA UDI
- Generic Name
- Shoulder humeral body prosthesis FDA UDI
- Device Name
- The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is designed to accommodate the natural humeral geometry, while providing stable fixation, proximal bone loading and proper head placement. FDA UDI
- Model / Reference
- BOD-0923-020-10STD FDA UDI
- Description
- The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is designed to accommodate the natural humeral geometry, while providing stable fixation, proximal bone loading and proper head placement. FDA UDI
Identifiers
- Catalog Number
- BOD-0923-020-10STD FDA UDI
- Primary DI / UDI-DI
- 10381780123187 FDA UDI
- 510(k) Number
- K142413 FDA UDI
- FDA Product Code
- HSD FDA UDIKWS FDA UDI
- GMDN Term
- Shoulder humeral body 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: Shoulder humeral body 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 Shoulder humeral body prosthesis.
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- Equinoxe — Exactech, Inc. · Class II
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- Anatomical Shoulder™ Domelock® — Zimmer, Inc. · Class II
- HemiCAP® — ARTHROSURFACE INCORPORATED · Class II
- Humeris Shoulder — FX SOLUTIONS · Class II
- OVOMotion™ — ARTHROSURFACE INCORPORATED · Class II
- HemiCAPOVO® — ARTHROSURFACE INCORPORATED · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI d0c9385c-8cc2-4bd7-a41f-6946e7ee3f7e 38 fields · synced May 30, 2026