The FDA has granted 510(k) clearance to an antibiotic-delivering knee spacer developed by Somerville, Mass.-based Mass General Brigham. The spacer delivers antibiotics directly to an infected artificial knee joint while bearing the patient’s weight.
Surgeons place the temporary spacer after removing an infected implant. It holds the joint space open until a new joint is implanted. The device embeds the antibiotic gentamicin in a durable plastic commonly used in joint implants, according to an October health system news release shared with Becker’s.
About 2% of knee replacements become infected. Standard bone cement spacers can offer limited support and release antibiotics unevenly. A 2025 study published in the Journal of Bone & Joint Surgery found the new design delivered higher, more sustained antibiotic release while keeping more than 90% of the plastic’s strength.
“Our goal was to create a spacer that can deliver antibiotics directly to the affected joint while remaining strong enough to support patients during treatment,” Orhun Muratoglu, PhD, director of the health system’s Harris Orthopaedics Laboratory, said in the release.
Mass General Brigham Innovation is licensing the technology to a large implant manufacturer, the release said.
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