Identity
- Trade Name
- Titan™ Reverse Shoulder System FDA UDI
- Generic Name
- Reverse shoulder prosthesis body FDA UDI
- Device Name
- The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increased ROM and minimized scapular notching, as well as increased visual and access to glenoid. The asymmatrix coating allows for an all press fit humeral component and secondary fixation. A titanium screw is included for fixation. FDA UDI
- Model / Reference
- BBS096021LRG FDA UDI
- Description
- The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increased ROM and minimized scapular notching, as well as increased visual and access to glenoid. The asymmatrix coating allows for an all press fit humeral component and secondary fixation. A titanium screw is included for fixation. FDA UDI
Identifiers
- Catalog Number
- BBS-0960-21LRG FDA UDI
- Primary DI / UDI-DI
- 10381780121541 FDA UDI
- 510(k) Number
- K130050 FDA UDI
- FDA Product Code
- KWS FDA UDI
- GMDN Term
- Reverse shoulder prosthesis body FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 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: Reverse shoulder prosthesis body
Titan™ Reverse Shoulder System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reverse shoulder prosthesis body.
- Duocentric® — Aston Medical · Class II
- BIO-MODULAR REVERSE SHOULDER — Biomet Orthopedics, Inc. · Class II
- Comprehensive® Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
- Identity™ — Zimmer, Inc. · Class II
- GLOBAL UNITE — DEPUY (IRELAND) · Class II
- Comprehensive Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
- Duocentric® — Aston Medical · Class II
- Comprehensive® — Zimmer, Inc. · Class II
Cleared under the same submission
K130050 also covers:
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ Reverse Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Reverse Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Reverse 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 d24369d7-68c3-42b5-ac98-9a44c7e25c2e 38 fields · synced May 30, 2026