The FDA gave 510(k) clearance to Zimmer Biomet Holdings, Inc.’s Persona Trabecular Metal (TM) Tibia in January 2018. CE Mark approval came in April 2018. On March 20, 2018, the first surgical case utilizing the device was performed by Richard Moore, M.D., of Boise, Idaho.
FDA Clearance Gives Zimmer Biomet “Fully Cementless” Knee
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On April 16, 2018, Zimmer Biomet’s Joint Reconstruction head, Dan Williamson, said, “Combined with the Persona TM Femur and the TM Patella, clearance of the Persona TM Tibia allows us to provide a fully cementless total knee solution. We believe this innovative product will position us to re-establish our leadership in the fully cementless primary knee market.”
Trabecular metal, according to the company, is a “porous biomaterial made from elemental Tantalum with structural, functional and physiological properties similar to cancellous bone. The material has been in use for over 20 years and used in over two million orthopedic devices.”
Indications of Use
The FDA clearance letter states the device is indicated for patients with severe knee pain and disability due to:
“- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
– Collagen disorders, and/or avascular necrosis of the femoral condyle.
– Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
– Moderate valgus, varus, or flexion deformities.
– The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.”
Predicate Devices
Predicate devices included the company’s Persona The Personalized Knee System, cleared November 7, 2012, and the NexGen Trabecular Metal Tibial Tray, cleared September 5, 2007.
The company told the FDA the purpose of this 510(k) submission was for a “specification update to the Persona Trabecular Metal tibial component, as well as to introduce new tibial instrumentation unique to the device.” It took the FDA about three months to clear the submission.
The company plans a limited launch of the tibia in the first half of this year, followed by a full commercial launch in the second half of 2018.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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