Custom Implants Delivered in One Day

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A Connecticut startup company says it will soon offer 24-hour turnaround service on custom cranial implants made from machined PEEK (polyetheretherketone) billets. Current products on the market require four to five weeks for delivery.

"We can do this because we don't outsource anything," says James Ketner, CEO of Kelyniam Global Inc. of Canton, CT.

The Kelyniam Custom Skull Implants (CSI) are designed and manufactured for each individual patient to correct or replace bony voids in the cranial skeleton caused by trauma or birth defects.

In a major milestone, Kelyniam last month received clearance from the U.S. Food and Drug Administration (FDA) to begin marketing its implants.

Kelyniam expects to ship its first custom implants in July or August, Ketner said in an interview with Design News. He said he could not divulge the names of the medical centers or surgeons he is working with.

Custom cranial implants are a mushrooming technology because of developments in CAD software and manufacturing processes.

Surgeons at Walter Reed Army Medical Center (WRAMC) in Washington, D.C. have been using additive manufacturing processes to produce custom cranial implants for several years.

They recently explored use of machined PEEK implants, but felt they were too expensive. Instead they opted for implants made from titanium alloy using an electron beam additive manufacturing (AM) process.

Ketner declined to comment on the cost of Kelyniam's implants, but said that machined PEEK offers superior strength and materials' properties compared to implants made with a laser sintering process.

He says the key is in the molecular orientation you can achieve in the machining process. In laser sintering, particles are formed into a large shape with a laser driven by a CAD model.

Another important factor is the rapid turnaround. Surrounding bone material can shift slightly after a few days, he says. Included in the 24-hour turnaround are a stereolithography master and a machined polyacetal model to confirm fit.

In a letter to shareholders last year, Ketner said that Kelyniam has the capacity to ship 1,500 implants (any type) per year. He projected theoretical revenues of $4.5 million based on that shipment level.

Kelyniam is a publicly traded company. Current stock prices are 30 cents a share.