With the October 22, 2019 FDA 510(k) clearance of the company’s cemented version Madison total knee implant, Bordeaux, France-based Implanet has added a knee offering to the its flagship JAZZ spine system.
Implanet Cemented Total Knee Cleared by FDA
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Madison Knee System
According to the FDA document, the Madison knee system is intended for total knee replacement. The components are for, “use in total knee arthroplasty to relieve pain and restore knee functions for indications such as: painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis, and revision of previous unsuccessful knee replacement or other procedure. These components are indicated for cemented fixation only.”
The modular knee system consists of a femoral component, tibial insert, tibial baseplate, tibial stem extensions, and a patella. “The system components are designed to be Cruciate-Retaining and Ultra-Congruent.”
The femoral component and tibial baseplate are manufactured from cobalt chrome and are to be implanted with cement. The tibial stem extensions are manufactured from titanium alloy, and the tibial insert and patella components are manufactured from UHMWPE (ultra-high molecular weight polyethylene). All implant components are provided sterile.
An October 29, 2019 company press releases states that this is “the first step towards targeted clearance of complete Total Knee Replacement (TKR) range. Robust clinical results, including data collected over 7 years and 17,000 implants, supported the clearance.”
Company CEO Ludovic Lastennet said with those 17,000 implants, “We have demonstrated the clinical value of our products. This clearance is fully in line with the strategic development of our partnership with KICo that aims to target, for Implanet’s knee division, the high-potential markets of Australia and the United States through KICo’s Florida-based subsidiary.”
The company was founded in 2007 and currently employs 38 staff with recorded 2018 sales of €6.7 million.
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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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