Additive Ortho wins FDA nod for 3D-printed customized foot & ankle implants

Additive OrthopaedicsAdditive Orthopaedics said yesterday that it won FDA 510(k) clearance for its patient specific 3D-printed locking lattice plates.

The newly cleared devices from the Little Silver, N.J.-based company now have indications from the federal watchdog for the alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as those in the foot and ankle.

“There will always be a need for traditional off-the-shelf orthopedic devices, but in cases of implant revisions, limb salvage, and trauma, using printing to manufacture a patient specific device can potentially lead to a better outcome.  Although we are still in the early stages for 3D printed patient specific implants, it has been a terrific journey developing the market in foot and ankle orthopaedics,” prez Greg Kowalczyk said in a press release.

Additive Ortho said that its patient specific implants will be the cornerstone of its Game Plan integrated surgical planning system which it hopes to launch later this year.

Last May, Additive Orthopaedics said that it won FDA 510(k) clearance for its Patient Specific 3D-printed bone segments.

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FDA clears Additive Ortho’s patient specific 3D printed bone segments

Additive Orthopaedics said yesterday it won FDA 510(k) clearance for its Patient Specific 3D-printed bone segments.

The 3D-printed segments are designed to address internal bone fixation in the ankle and foot, the Little Silver, N.J.-based company said.

“This is a tremendous milestone for orthopaedics and the obvious trend towards patient specific 3D printed implants.  In cases of implant revision, limb salvage, and trauma, often there are no clinically available devices to address the patient’s condition.  This is where 3D printed patient specific implants are making significant clinical impacts,” president Greg Kowalczyk said in a press release.

“Our lattice structures are proving to be the next generation design as opposed to the older, more open, types of structures that rely on biologics for osteosynthesis.  In several patients, our lattice structures have shown close to 90% boney in-growth after 6 months using no biologics. We are excited to now offer these as patient specific solutions,” engineering & ops VP Brian McLaughlin said in a prepared release.

Additive Orthopedics said that it recently closed a Series B round of financing, bringing in $1 million.

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