đź“‹ FDA Reference
titan total shoulder system tss titan reverse shoulder system rss titan humeral resurfacing arthroplasty system hra modular radial head system mrh katalyst bipolar radial head system katalyst
Smith & Nephew
Summary: The Titan Shoulder Systems by Smith & Nephew are orthopedic devices used in shoulder arthroplasty procedures. They are designed for use by orthopedic surgeons to treat patients with shoulder joint issues.
FDA Clearance Information
Pathway
510K
Number
K213827 ↗
Decision Date
March 11, 2022
Product Code
KWS
Device Class
Class 2
Evidence
0 studies
The Titan Shoulder Systems were cleared through the FDA 510(k) pathway on March 11, 2022. Manufactured by Smith & Nephew, these devices are classified as Class 2 under product code KWS.
What It Is
The Titan Shoulder Systems include the Total Shoulder System (TSS), Reverse Shoulder System (RSS), and Humeral Resurfacing Arthroplasty System (HRA), among others. These systems are modular and designed for shoulder joint replacement surgeries. They aim to restore function and reduce pain in patients with degenerative shoulder conditions or severe fractures.
Clinical Applications
These devices are commonly used in orthopedic surgeries, particularly in patients with arthritis, rotator cuff tear arthropathy, or complex fractures of the shoulder. They are utilized in both elective and trauma settings, primarily by orthopedic surgeons. The systems are suitable for adult patients who require joint replacement to regain mobility and alleviate pain.
Indications for Use
The FDA indications suggest these devices are intended for patients requiring shoulder joint replacement due to conditions like osteoarthritis, rheumatoid arthritis, or severe shoulder fractures. They are also used in cases where previous joint replacements have failed.
Practical Considerations
The Titan Shoulder Systems offer modular components that allow for customization to fit various patient anatomies. Surgeons should be familiar with the specific surgical techniques required for implantation and ensure compatibility with existing patient anatomy.
Frequently Asked Questions
What is the Titan Shoulder System used for?
The Titan Shoulder System is used for shoulder joint replacement surgeries to treat conditions like arthritis or severe fractures.
What specialties typically use this device?
Orthopedic surgeons typically use this device in both elective and trauma settings.
What are the FDA-cleared indications?
The device is indicated for patients needing shoulder joint replacement due to arthritis, severe fractures, or failed previous replacements.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.