Orthopedic implants

Crescom wins FDA clearance for bone analysis

Wed, 24 Dec 2025 11:00:00 -0500

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.

Amber Vcfix spinal system shows promising data

Tue, 03 Jun 2025 12:00:00 -0400

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.

Discure looks to reverse disc degeneration with implantable device

Fri, 07 Mar 2025 11:00:00 -0500

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.

PTAB affirms rejection of 2014 patent application for cartilage

Wed, 05 Mar 2025 11:00:00 -0500

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.

Globus Medical buying chronic pain company Nevro for $250M

holland.johnson@clarivate.com — Thu, 06 Feb 2025 11:00:00 -0500

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.

Stryker sells spine implants business, sales up

Wed, 29 Jan 2025 11:00:00 -0500

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.

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

Wed, 18 Dec 2024 11:00:00 -0500

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.

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

Wed, 19 Jun 2024 12:00:00 -0400

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.

Cgbio plans US entry of Novosis Putty, presents Novosis study

Mon, 20 May 2024 12:00:00 -0400

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.

Red light therapy found to help regenerate spinal cord cells

Thu, 09 May 2024 12:00:00 -0400

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.

US FDA wary of predicate devices in draft guidance for jawbone grafts

Mon, 01 Apr 2024 12:00:00 -0400

The U.S. FDA issued a draft guidance for premarket applications for class II bone grafting devices, a policy that would supplement a guidance issued nearly two decades ago.

Renovos wins breakthrough device designation for nanoclay gel

Thu, 04 Jan 2024 11:00:00 -0500

Renovos Biologics Ltd. was granted a U.S. FDA breakthrough device designation for its Renovite BMP-2 (bone morphogenetic protein-2) product, which is designed for interbody spinal fusion.

Bongenix granted patent by USPTO for stimulating bone growth with electricity

Mon, 06 Nov 2023 11:00:00 -0500

Bongenix LLC reported the issuing of its very first patent, in which a non-invasive bone stimulating method and device are described for treating injured or diseased bone tissue with electricity.

New 3D printing process to tailor-make medical devices combats bacterial resistance

Tue, 15 Jun 2021 13:00:00 -0400

A new 3D printing technique has allowed University of Nottingham researchers to tailor-make artificial body parts and other medical devices that are both implantable and bacteria-resistant. The multi-materials manufactured in the study were also adapted to 3D printing technology that is able to offer devices that can better meet the need of the patient and minimize the surgeries led by device failure that increase the risk of infections.

Kinos and Restor3d merge to step up their presence in the foot and ankle market

Mon, 17 May 2021 13:00:00 -0400

Restor3d Inc. added a new dimension to its offerings with its merger with Kinos Medical Inc. The combination will increase Restor3d’s presence in the foot and ankle repair and replacement market by adding the Kinos Axiom total ankle system to its portfolio of 3D-printed implants using biomedical materials in a variety of applications.

Orthofix gets approval for Construx 3D cervical spacer

Mon, 05 Apr 2021 13:00:00 -0400

The FDA has granted 510(k) clearance to Orthofix Medical Inc.’s Construx Mini Ti spacer system for anterior cervical discectomy and fusion (ACDF) procedures. Company documents claim the implant has an optimized porosity and pore size, which creates a 3D porous surface with the potential for bone ingrowth.

Rsip Vision releases joint segmentation tool for revision arthroplasty and other orthopedic procedures

Wed, 24 Mar 2021 13:00:00 -0400

HONG KONG – Israel and U.S.-based Rsip Vision Ltd. unveiled an advanced joint segmentation tool to assist with the planning of revision arthroplasty and other orthopedic procedures for patients with pre-existing metal implants. The detailed, noninvasive artificial intelligence (AI)-based software module enables quick and accurate segmentation of different joints from CT scans of hips, knees, shoulder and spines.

Solvay partners with Printerprezz to develop 3D printing solutions for medical devices

Mon, 04 Jan 2021 13:00:00 -0500

PARIS – Solvay SA is partnering with Printerprezz Inc. to develop 3D printing technology using Selective Laser Sintering (SLS) for implants and other medical devices.

Regeltec’s Hydrafil gets breakthrough nod for back pain

Wed, 09 Dec 2020 12:00:00 -0500

A percutaneous hydrogel treatment for chronic low back pain has won a U.S. FDA breakthrough device designation. The status will enhance interactions between Baltimore, Md.-based Regeltec Inc. and the agency during regulatory review of the Hydrafil implant, accelerating the path to clinical trials and commercialization.

Ziptek develops novel orthopedic fixation device

Tue, 10 Mar 2020 11:00:00 -0400

BOGOTA, Colombia – Ziptek Mexico, from Hermosillo, Mexico, is working to revolutionize the sutures market with an innovative product that is already making its way to the U.S. surgical orthopedic device market. Plans to expand across Latin America are progressing.

Surgeons come together to create Field Orthopaedics to address market shortcomings

Fri, 14 Feb 2020 12:00:00 -0500

PERTH, Australia – Brisbane, Australia-based Field Orthopaedics was formed when a group of orthopedic surgeons were exasperated by ongoing shortcomings in surgical practice and decided to do something about it.

BioWorld MedTech’s Orthopedics Extra for Jan. 22, 2020

holland.johnson@clarivate.com — Wed, 22 Jan 2020 12:00:00 -0500

Keeping you up to date on recent developments in orthopedics, including: Renovos Biologics

Think Surgical gets FDA nod for Tsolution One

Fri, 11 Oct 2019 00:00:00 -0400

Think Surgical Inc., of Fremont, Calif., won good news from the U.S. FDA, which cleared the company's Tsolution One total knee application for use in total knee arthroplasty (TKA). The Tsolution One total knee application includes computed tomography-based 3D presurgical planning software, providing surgeons the ability to design and prepare the patient's knee joint replacement plan. During surgery, the physician puts the patient's pre-planned procedure using the robot into effect, with the goal of precisely placing the knee implants.

Researchers test the first neuroprosthetic leg, now aim for a larger, longer study

Fri, 04 Oct 2019 00:00:00 -0400

Arm and hand prosthetics have long been the focus for researchers aiming to offer sensation as well as more precise and easily controlled movement by connecting patient nerves to sensors in the prosthetic. But now that effort has been extended to leg prosthetics as well.