📋 FDA Reference
Pritchard Surface Replacement Elbow
Summary: The Pritchard Surface Replacement Elbow is a medical device used in elbow joint arthroplasty, particularly for patients with conditions like rheumatoid arthritis. It is primarily used by orthopedic surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K810847 ↗
Decision Date ?
May 1, 1981
Product Code ?
JDB
Device Class ?
Class 2
Evidence ?
0 studies
The Pritchard Surface Replacement Elbow was cleared through the FDA 510(k) pathway on May 1, 1981. Manufactured by Depuy, it is a Class 2 device under product code JDB.
What It Is
The Pritchard Surface Replacement Elbow is a type of elbow prosthesis designed to replace the articulating surfaces of the elbow joint. It is typically used in patients with severe joint damage due to conditions like rheumatoid arthritis. This device allows for improved joint function and pain relief by replacing the damaged surfaces with metal and polyethylene components.
FDA-Cleared Indications
- Elbow joint arthroplasty for severe destruction or degeneration of the elbow joint.
- Replacement of damaged elbow articulating surfaces in appropriately selected patients with adequate bone and ligament support.
- Use in patients whose elbow pain and functional loss are related to conditions such as rheumatoid arthritis or traumatic joint damage, when consistent with the device labeling.
Clinical Applications
- Surface replacement elbow arthroplasty.
- Treatment of severe elbow joint damage associated with rheumatoid arthritis.
- Treatment of selected post-traumatic elbow joint destruction.
- Replacement of damaged elbow joint surfaces when bone quality and ligamentous stability are adequate.
Practical Considerations
- The implant is selected and sized to match the patient's elbow anatomy and available bone stock.
- Successful placement requires accurate surgical preparation, alignment and assessment of ligament stability.
- The device is a metal-and-polyethylene elbow prosthesis; surgeons should confirm component compatibility and follow the applicable surgical technique and labeling.
- Patients with inadequate bone stock, severe instability or other contraindications may not be appropriate candidates.
- MRI safety and conditions should be confirmed from the current implant documentation; an older FDA record alone does not establish that the device is MR Safe or MR Conditional.
Related Literature
The linked study examined total elbow arthroplasty in patients with rheumatoid arthritis, highlighting improvements in outcomes due to better patient selection and implant design. It found that semiconstrained implants are suitable for severe cases, while non-constrained surface replacements, like the Pritchard device, require intact bone and ligaments. Limitations include the study's focus on a specific patient population and the need for early intervention.
Frequently Asked Questions
What is the Pritchard Surface Replacement Elbow used for?
It is used for elbow joint replacement in patients with severe joint damage, particularly due to rheumatoid arthritis.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement and arthroplasty procedures use this device.
What are the FDA-cleared indications?
The device is indicated for elbow joint replacement in patients with severe damage and intact bone and ligament support.
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.