Additive Manufacturing Strategies

Additive Orthopaedics Receives 510(k) Clearance for Patient Specific 3D Printed Bone Segments

ST Medical Devices

Share this Article

It seems like just about every day, we’re learning of new 3D printing innovations in the medical field, from prosthetics and pharmaceuticals to anatomical models, surgical guides, and implants. But none of these can get very far in the market, and into the hands of the doctors and patients who need them the most, without receiving the very important stamp of approval from the US Food and Drug Administration (FDA).

The agency has to take many factors into account when deciding if a product or device is safe to use – it’s not an easy job, and the FDA often asks for feedback and publishes guidance regarding 3D printing. Still, not everything gets that necessary approval to move forward, so when companies do receive clearance, it’s a big deal.

Early stage orthopaedic company Additive Orthopaedics, LLC is on a mission to integrate biologics (biopharmaceuticals) and advanced manufacturing, in order to ensure a better outcome for the patient. The company is a leader in the 3D printed orthopaedic foot and ankle device market, and received FDA clearance for its first product, a 3D printed titanium digital fusion implant, in the summer of 2016. A month later, the FDA granted Additive Orthopaedics clearance for its 3D printed hammertoe implants, and soon after for its 3D printed osteotomy wedge system, which address bone fractures and osteotomies in the ankle and foot.

By June of 2017, the young company, which only launched its first commercial product line a year ago, received 510(k) clearance from the FDA for a fourth 3D printed device – the intermedullary, minimally invasive Bunion Correction System, which includes a 3D printed implant meant to align and stabilize bunions.

In its short history, Additive Orthopaedics has seen over 1,000 of its devices implanted, and has also developed and patented multiple design structures, which are only possible thanks to 3D printing, that are used in its current and future products. These include its AddBone implant surface technology, Biologic Interface, and its Variable Honeycomb Lattice (VHL) design, which is optimized to allow enhanced bony in-growth throughout the implant structure while remaining strong.

Now, Additive Orthopaedics is sharing more good news – it has received FDA 510(k) clearance for its Patient Specific 3D Printed Bone Segments for the global extremities market.

“This is a tremendous milestone for orthopaedics and the obvious trend towards patient specific 3D printed implants,” said Greg Kowalczyk, the President of Additive Orthopaedics. “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.”

The company’s Patient Specific 3D Printed Bone Segments were developed to address internal bone fixation in the feet and ankles, which requires surgery to internally set and stabilize fractured bones.

“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,” explained Brian McLaughlin, the Vice President of Engineering and Operations at Additive Orthopaedics. “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.”

In other company news, Additive Orthopaedics also closed a $1 million Series B round of financing recently.

Discuss this story and other 3D printing topics at 3DPrintBoard.com or share your thoughts in the Facebook comments below. 

[Images: Additive Orthopaedics]

 

Share this Article


Recent News

3D Printing Robots Receive €1 Million Boost

3D Printing People: A Dialogue Beyond Industry at TIPE 2022



Categories

3D Design

3D Printed Art

3D Printed Food

3D Printed Guns


You May Also Like

3D Printing Webinar and Event Roundup: January 16, 2022

We’re back in business this week with plenty of webinars and events, both virtual and in-person, starting with the second edition of the all-female-speaker TIPE 3D Printing conference. There are...

Women in 3D Printing’s Posts Agenda for TIPE Conference and Virtual Career Fair

This January 18-20, Women in 3D Printing (Wi3DP) is back for the second time in a row with its TIPE 3D Printing Conference and Virtual Career Fair. Like its inaugural...

Women in 3D Printing Onboards New President

As the nonprofit celebrates seven years of supporting women in the additive manufacturing (AM) industry, Women in 3D Printing (Wi3DP) has taken on a new leader. Kristin Mulherin is taking...

3D Printing Trade Show Best Practices: Food and Food for Thought

This is the third installment of ideas, suggestions, and best practices for your 3D printing stand from an interested observer. We previously discussed booth location and how best to connect...


Shop

View our broad assortment of in house and third party products.