TITAN Modular Total Shoulder System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142413 FDA 510(k)
- FDA Product Code
- KWS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3660 FDA 510(k)
- Regulation Number
- 888.3660 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TITAN Modular Total Shoulder System is a modular total shoulder arthroplasty system designed for use in shoulder joint replacement procedures. It consists of interchangeable components intended to restore shoulder function and stability in patients requiring total shoulder arthroplasty.
The system is supplied non-sterile and is intended for single use. It is used in orthopedic surgical settings and has received FDA 510(k) clearance under K142413 with product code KWS. The device is manufactured by Ascension Orthopedics and is regulated as a Class II medical device.
Frequently asked questions
What is the TITAN Modular Total Shoulder System used for?
The TITAN Modular Total Shoulder System is designed for use in shoulder joint replacement procedures to restore shoulder function and stability in patients requiring total shoulder arthroplasty, as it consists of interchangeable components intended for this specific orthopedic application.
How is the TITAN Modular Total Shoulder System supplied and is it reusable?
The system is supplied non-sterile and is intended for single use only, meaning it must not be reused after a surgical procedure to ensure patient safety and device integrity.
What regulatory pathway was used for the TITAN Modular Total Shoulder System?
The device received FDA 510(k) clearance under submission number K142413, indicating it was found substantially equivalent to a legally marketed predicate device, and is regulated as a Class II medical device with product code KWS.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142413 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ascension Orthopedics
Sources (1)
- FDA 510(k) K142413 24 fields · synced Sep 21, 2026