The FDA finalized its guidance on patient-matched guides for orthopedic implants. These guides have become a familiar part of orthopedic and spine surgery, and the FDA’s May 7 document sets expectations for manufacturers and surgeons.
10 things to know:
1. Manufacturers should clearly identify which planning parameters surgeons can modify and at which steps in the process surgeon input is accepted, according to the FDA.
2. A surgeon’s review and concurrence with the pre-operative plan is a documented, required step in the manufacturing process.
3. The FDA makes it clear that a patient-matched guide must sit in a clear, unique, and stable position on the patient’s anatomy.
4. If a manufacturer reduces image resolution in the planning software, the FDA requires them to label those images as preoperative only and not intended for diagnostics.
5. Every guide must be individually identified for the specific patient it was made for, and identification has to be placed on the guide itself.
6. Manufacturers are required to describe a conversion pathway to conventional manual instrumentation. Before all cases surgeons should have a fallback plan.
7. The FDA also says the imaging modality used to design a guide is part of its cleared indication. This means switching from MRI to CT or vice versa is considered a significant device modification that requires a new FDA submission.
8. Because patient-matched guides depend on precise geometry to seat correctly, the FDA requires manufacturers to test that guides do not deform during sterilization, cleaning, or shipping.
9. The FDA requires that the maximum allowable time between image acquisition and surgery be defined based on the rate at which the patient’s anatomy may change. For patients with progressive deformity, significant arthritis, or rapidly evolving pathology, a guide planned months earlier may no longer accurately reflect the surgical site.
10. If a manufacturer’s sales materials or labeling suggest that their patient-matched guide improves patient outcomes compared to conventional instrumentation, the FDA requires clinical evidence to back that up.
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