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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 ?
510(k)
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.
FDA-Cleared Indications
- Shoulder joint resurfacing in patients with painful and disabling joint disease.
- Use in patients with degenerative arthritis of the shoulder.
- Use in patients with rotator cuff arthropathy when the humeral head requires resurfacing.
Clinical Applications
- Humeral head resurfacing during shoulder arthroplasty.
- Treatment of painful shoulder arthritis that has not improved adequately with nonsurgical treatment.
- Treatment of selected shoulder degeneration associated with rotator cuff arthropathy.
- Reconstruction of the damaged humeral side of the shoulder joint using a size-matched implant.
Practical Considerations
- The system includes multiple humeral head and CTA humeral head sizes; the surgeon selects components based on the patient's anatomy and the condition of the shoulder.
- Correct component compatibility, bone preparation, alignment and fixation are important for implant function and durability.
- Contraindications and precautions may include active infection, inadequate bone stock, severe bone loss, inability to follow postoperative restrictions and conditions that prevent stable fixation; the complete FDA labeling should be reviewed.
- MRI safety depends on the complete implanted construct and the manufacturer's current testing and labeling. Patients should tell MRI staff about the implant before imaging.
- The implant is placed through open orthopedic surgery, usually with regional anesthesia, general anesthesia or both; recovery includes physical therapy and activity restrictions.
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.