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BioWorld - Saturday, December 27, 2025
Home » Topics » Medical devices » Orthopedic implants

Orthopedic implants
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Crescom MediAI-BA

Crescom wins FDA clearance for bone analysis

Dec. 24, 2025
By Marian (YoonJee) Chu
Crescom Co. Ltd., an AI musculoskeletal imaging company, gained U.S. FDA 510(k) clearance Dec. 24 for MediAI-BA, its AI-powered pediatric and adolescent bone age analysis software. Classified as a class II medical device, MediAI-BA evaluates bone age and suggests predicted adult height based on growth plate status assessed by hand and wrist X-ray imaging. Prior clinical trial results demonstrated MediAI-BA had specialist-level accuracy, recording a mean absolute deviation (MAD) of 0.39 years.
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Amber Implants VCFix Spinal System

Amber Vcfix spinal system shows promising data

June 3, 2025
By Shani Alexander
Amber Implants BV reported no device-related adverse events were seen in any of the patients fitted with its Vcfix spinal system, which treats vertebral compression fractures, at one-year. Data from the first-in-human trial of the device also showed patients experienced a significant reduction in their pain levels.
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Discure Technologies Discure system

Discure looks to reverse disc degeneration with implantable device

March 7, 2025
By Shani Alexander
With millions of people suffering from chronic back pain, Discure Technologies Ltd. is hoping that its bioelectronic therapy, the Discure system, will soon bring relief.
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3D illustration of knee joint

PTAB affirms rejection of 2014 patent application for cartilage

March 5, 2025
By Mark McCarty
The widespread need for cartilage repair may have bred optimism on the part of Spinalcyte LLC when it filed a related patent in 2014, but the Patent Trial and Appeal Board has affirmed a rejection of the patent due to lack of enablement, an object lesson regarding the need for clarity in patent applications.
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Acquisition puzzle

Globus Medical buying chronic pain company Nevro for $250M

Feb. 6, 2025
By Holland Johnson
Globus Medical Inc. reported it is buying Nevro Corp. in an all-cash transaction. Under the terms of the agreement, which was unanimously approved by the boards of both companies, Globus will acquire all shares of Nevro for $5.85 per share. The transaction represents a total equity value of approximately $250 million.
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Hands holding torn contract

Stryker sells spine implants business, sales up

Jan. 29, 2025
By Annette Boyle
In a remarkably news-filled earnings call on Jan. 28, Stryker Corp. revealed plans to sell its U.S. and spinal implants business to Viscogliosi Brothers LLC for an undisclosed sum, announced the retirement of Chief Financial Officer Glenn Boehnlein on April 1, reported sales growth of 11% for the fourth quarter and 10% for the full year 2024 and said the $4.9 billion acquisition of Inari Medical Inc. should close by the end of February.
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Smith+Nephew AETOS Stemless shoulder implant

S&N gets FDA clearance for stemless anatomic total shoulder implant

Dec. 18, 2024
By Shani Alexander
Smith & Nephew plc received U.S. FDA 510(k) clearance for Aetos Stemless, its stemless anatomic total shoulder implant. The greenlight for the device is a boon for the company’s orthopedics portfolio, which faces increasing pressure from U.S. competitors.
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Inosys 3d-print spine implant

Inosys Korea gains FDA nod for 3D-printed cervical spine cage

June 19, 2024
By Marian (YoonJee) Chu
Inosys Korea Co. Ltd. gained U.S. FDA 510(k) clearance for Unispace, a cervical spine cage manufactured with 3D printing technology. Unispace can be used during spinal fusion surgery, Busan-based Inosys said, wherein operators can remove a patient’s diseased or damaged disc and replace it with the cervical cage to maintain the original length of the spine.
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Novosis Excelos Inject

Cgbio plans US entry of Novosis Putty, presents Novosis study

May 20, 2024
By Marian (YoonJee) Chu
After Novosis Putty gained U.S. FDA breakthrough device designation of bio-fusion spine implantation device, South Korea’s Cgbio Co. Ltd. posted positive findings of similar ceramic bone graft, Novosis, to lay groundwork for U.S. market entry.
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3D illustration of transparent human torso with close up of spinal cord

Red light therapy found to help regenerate spinal cord cells

May 9, 2024
By Shani Alexander
Researchers have developed a method to repair nerve connections in patients with spinal cord injuries using red and near-infrared light. The team from the University of Birmingham, U.K., are now planning to develop an implantable device to help surgeons protect and repair the spinal cord.
Read More
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