iBalance TKA System

Arthrex

Not determinedIndexed from FDA records

MR Conditional — conditions not yet documented here. We have a Conditional label for this device but the specific scan conditions (field strength, SAR / B1+rms, monitoring requirements) aren't in our records yet. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.

Don't schedule an MRI based on this page alone — your MRI team verifies every device.

What this means for you

MR Conditional — but the conditions are not yet on file. The label exists. The scan rules (field, SAR, monitoring) do not. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
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For information only — your MRI team makes the final decision before any scan. They check every patient, every time.

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

12/16/2015 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

12/16/2015 · View on FDA.gov

⚕️ This information is for reference only. A recall does not necessarily mean your device needs removal. Consult your healthcare provider for medical advice.

Regulatory Info

No 510(k) clearance data available for this device.

✅
All Recalls Resolved

2 past recalls — all corrective actions completed

Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.

Category

Joint Replacement

Body Region

Knee

MRI Conditions

MR Conditional. Specialized total knee arthroplasty system from sports medicine leader. Standard precautions apply.

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Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.