đź“‹ FDA Reference
smr resurfacing shoulder system- humeral heads cta humeral heads
Lima Corporate S.P.A.
Summary: The SMR Resurfacing Shoulder System by Lima Corporate is used for shoulder joint resurfacing, particularly in patients with arthritis or rotator cuff arthropathy. It is typically used by orthopedic surgeons.
FDA Clearance Information
Pathway
510K
Number
K112900 ↗
Decision Date
June 1, 2012
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
The SMR Resurfacing Shoulder System was cleared by the FDA via the 510k pathway on June 1, 2012. Manufactured by Lima Corporate S.P.A., it is classified as a Class 2 medical device.
What It Is
The SMR Resurfacing Shoulder System is a surgical implant designed for shoulder joint resurfacing. It includes humeral heads and CTA humeral heads, which are used to replace the damaged surfaces of the shoulder joint. This system helps restore function and reduce pain in patients with degenerative shoulder conditions.
Clinical Applications
This device is commonly used in orthopedic surgery for patients with shoulder arthritis or rotator cuff arthropathy. It is suitable for use in hospital settings and specialized orthopedic centers. The typical patient population includes adults with significant shoulder joint degeneration who require surgical intervention to improve mobility and reduce pain.
Indications for Use
The FDA indications suggest this device is intended for patients with shoulder joint conditions such as arthritis or rotator cuff issues. It is used to resurface the joint, providing pain relief and improved function.
Practical Considerations
The SMR Resurfacing Shoulder System comes in various sizes to accommodate different patient anatomies. Surgeons should consider compatibility with existing shoulder anatomy and ensure proper surgical technique to achieve optimal outcomes.
Frequently Asked Questions
What is SMR Resurfacing Shoulder System used for?
It is used for shoulder joint resurfacing in patients with arthritis or rotator cuff arthropathy.
What specialties typically use this device?
Orthopedic surgeons specializing in shoulder surgeries typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with shoulder joint conditions like arthritis or rotator cuff issues, aiming to improve joint function and reduce pain.
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.