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Home » Topics » Disease categories and therapies » Orthopedics

Orthopedics
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Ifuse Bedrock Granite Implant

Two FDA clearances to improve spinal surgery

May 31, 2022
By Annette Boyle
More than 1.6 million spinal procedures are performed in the U.S. each year and between 10% and 30% of them fail to achieve their objective, indicating that the field has abundant room for improvement. Both equipment manufacturers and the FDA hope to improve spinal surgery success rates as seen in two clearances granted on May 31.
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Bonesupport Cerament components

Bonesupport wins FDA nod for first antibiotic-eluting bone graft

May 19, 2022
By Meg Bryant
The U.S. FDA has granted de novo approval for Bonesupport AB’s Cerament G, an antibiotic-eluting bone graft designed to osteomyelitis. The company plans to launch in the U.S. in late September or early October.
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Digital spine concept art

Nanox unit wins FDA clearance for spine analysis device

May 6, 2022
By Gina Lee
Nano-x Imaging Ltd.’s (Nanox) subsidiary Nanox.AI has received the FDA’s 510(k) clearance for Healthost, an artificial intelligence (AI) software device providing qualitative and quantitative analysis of the spine from CT scans.
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In boon to sector, surgical robots receive NMPA approvals

April 29, 2022
By Zhang Mengying
The NMPA approved two different surgical robots for marketing, a step forward in growth of a sector that remains underdeveloped in China. One of the robots approved for marketing by the NMPA is from Yuanhua Orthopedic Robotic Ltd. and the other is Suzhou Microport Orthobot Co. Ltd. Both robots are used for total knee arthroplasty (TKA), removing damaged cartilage and bones from the surface of the knee joint and replacing them with artificial implants.
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FDA adds orthopedic fracture fixation plates to device types eligible for 510(k) alternative

April 14, 2022
By Mark McCarty
The U.S. FDA’s safety and performance-based pathway (SPBP) is intended as a leaner, meaner alternative to the conventional 510(k) pathway that would sidestep some of the presumed problems with the concept of substantial equivalence. The agency recently added four device types to this program, including orthopedic fracture fixation plates.
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Ossio suture anchor, composition illustration

Ossio suture anchors for shoulder repair get FDA thumbs up

April 11, 2022
By David Godkin
Ossio Inc. has received FDA clearance for Ossiofiber suture anchors used to fix soft tissue to bone in the shoulder, foot and ankle. This is the most recent of clearances for the company’s intelligent bone regeneration technology which began in 2019 as a possible alternative to permanent fixation implants for the foot and ankle alone.
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Computer screen displaying Keops software

SMAIO raises $10M in IPO to ramp commercial roll-out of its spinal fusion technology

April 7, 2022
By Bernard Banga
Software Machines and Adaptive Implants in Orthopedics (SMAIO) SA raised $10 million on the Paris Euronext Growth market. The offer price was set at $6.66 a share. “Thanks to this IPO, we will now be able to ramp commercial development of our I-Kontrol arthrodesis platform in Europe and secure a foothold in the United States,” Philippe Roussouly, CEO of SMAIO SA, told BioWorld.
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3D illustration of Agili-C in knee joint

Bioventus mobilizes to acquire Agili-C developer in deal valued up to $450M

April 5, 2022
By Annette Boyle
Bioventus LLC continues to strengthen its portfolio through acquisitions and investments with a move to exercise its option to purchase Cartiheal Ltd. for $315 million up front and a potential payment of $135 million contingent on achievement of $100 million in trailing 12-month sales. The Cartiheal transaction follows the acquisition of Bioness Inc. and Misonix Inc. last year. Cartiheal developed the Agili-C implant, which received FDA breakthrough device designation in 2020 and premarket approval last week.
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Illustration of the Balancedback total joint replacement device in the spine

3Spine raises $33M to advance first total joint replacement for the lower back

April 1, 2022
By David Godkin
3Spine Inc. has raised $33 million in an oversubscribed series C private offering for a phase II clinical study to assess what it calls “the first total joint replacement” for the lower back. This brings total private investment in the Balancedback total joint replacement to $50.3 million, largely due, said 3Spine CEO Marc Peterman, to “tremendous clinical outcomes and a mountain of benchtop research.”
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Back pain

Neuroone touts longevity stimulation data for electrode film tech

March 3, 2022
By Catherine Longworth
A thin film electrode platform technology developed by Neuroone Medical Technologies Corp. could be used to treat chronic back pain according to new tests. Eden Prairie, Minn.-based Neuroone said it concluded initial testing that demonstrate the electrode could provide chronic stimulation at typical stimulation parameters currently used to treat patients suffering with chronic back pain due to multiple failed back surgeries.
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