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Orthopedics

Early study supports experimental hydrogel injection for chronic low back pain

June 13, 2022 By Sean Whooley

A study demonstrated that an experimental hydrogel formulation was safe and effective in substantially relieving chronic low back pain. Research presented at the Society of Interventional Radiology Annual Scientific Meeting in Boston supported the hydrogel, which was injected into spinal discs in an effort to relieve chronic low back pain caused by degenerative disc disease […]

Filed Under: Clinical Trials, Drug-Device Combinations, Orthopedics, Pain Management, Spine Tagged With: hydrogel, hydrogels, ReGelTec

Si-Bone wins FDA clearance for expanded iFuse-TORQ implant indication

June 13, 2022 By Sean Whooley

Si-Bone announced today that the FDA granted clearance for its iFuse-TORQ implant for pelvic fracture fixation. The regulatory nod expands Si-Bone’s iFuse-TORQ’s indication for acute, non-acute and non-traumatic pelvic fractures, including pelvic fragility fractures (fractures related to low-energy traumatic events) and pelvic insufficiency fractures. Santa Clara, California-based Si-Bone said in a news release that the […]

Filed Under: 510(k), Food & Drug Administration (FDA), Implants, Orthopedics, Regulatory/Compliance Tagged With: Si-Bone

Onkos Surgical to acquire Stryker’s Juvenile Tumour System

June 13, 2022 By Sean Whooley

Onkos Surgical announced today that it agreed to acquire the Juvenile Tumour System (JTS) from Stryker (NYSE:SYK). Parsippany, New Jersey–based Onkos entered into a definitive agreement with the orthopedic technology giant over the system designed to enable limb stabilization and growth in pediatric patients affected by bone cancers, severe arthropathy, severe trauma, revisions, oncology and […]

Filed Under: Business/Financial News, Featured, News Well, Oncology, Orthopedics Tagged With: Onkos Surgical, Stryker

FDA clears lumbar interbody fusion device from Zavation Medical

June 10, 2022 By Sean Whooley

Zavation Medical announced today that it received FDA 510(k) clearance for its eZspand lateral expandable lumbar interbody fusion device. Flowood, Mississippi-based Zavation designed the eZspand lateral, part of the Zavation eZspand interbody system, with precision and continual expansion to offer an optimized fit for each patient, allowing for the enhancement of structural stability and improved […]

Filed Under: 510(k), Food & Drug Administration (FDA), Implants, Orthopedics, Regulatory/Compliance, Spine Tagged With: zavationmedical

Smith+Nephew is moving out of its historic U.K. home

June 9, 2022 By Chris Newmarker

Smith+Nephew (LSE:SN, NYSE:SNN) announced today that it will build a new R&D and manufacturing facility for its Advanced Wound Management franchise that will move the company outside of its historic home of Hull. S+N started in 1856 in Hull. The new R&D and manufacturing hub will be at the Melton West business park — about […]

Filed Under: Business/Financial News, Featured, News Well, Orthopedics, Wound Care Tagged With: Smith+Nephew

Paragon 28 launches Monkey Rings circular external fixation system

June 9, 2022 By Danielle Kirsh

Paragon 28 this week announced that it launched its Monkey Rings circular external fixation system for trauma, deformity correction and limb salvage. Englewood, Colorado-based Paragon 28 designed the circular external fixation system to use external wires and screws that can be fixed into the bone to maintain anatomic position. The system provides stability, soft-tissue preservation […]

Filed Under: Orthopedics Tagged With: Paragon 28

InVivo Therapeutics completes enrollment in study of Nuero-Spinal Scaffold

June 2, 2022 By Sean Whooley

InVivo Therapeutics (Nasdaq:NVIV) announced today that it completed enrollment in the Inspire 2.0 study for patients with acute spinal cord injury. Cambridge, Massachusetts–based InVivo’s 20-patient randomized, controlled trial aims to enhance the clinical evidence for the company’s Neuro-Spinal Scaffold. The company designed the Neuro-Spinal Scaffold to encourage functional cells to fill a cavity that will […]

Filed Under: Clinical Trials, Implants, Neurological, Spine Tagged With: InVivo Therapeutics

Orthofix announces 5-year positive data for its M6-C artificial cervical disc

May 31, 2022 By Chris Newmarker

Orthofix Medical (Nasdaq:OFIX) today announced positive five-year data from the single-level IDE study of its M6-C artificial cervical disc. Lewisville, Texas–based Orthofix will hold a presentation of the data on June 3 at the International Society for the Advancement of Spine Surgery annual meeting in Nassau, Bahamas. It’s been more than three years since FDA […]

Filed Under: Clinical Trials, Orthopedics, Spine Tagged With: Orthofix

Stryker’s spine guidance software wins FDA clearance

May 31, 2022 By Sean Whooley

Stryker (NYSE:SYK) announced today that its Q Guidance System for advanced surgery planning received FDA 510(k) clearance. Kalamazoo, Michigan–based Stryker designed the Q Guidance system for use with its spine guidance software for advanced planning and intraoperative guidance that enables open or percutaneous computer-assisted surgery. Q Guidance offers multiple tracking options, sophisticated software algorithms and […]

Filed Under: 510(k), Business/Financial News, Food & Drug Administration (FDA), Health Technology, News Well, Orthopedics, Regulatory/Compliance, Software / IT, Spine, Surgical Tagged With: FDA, Stryker

DJO’s Enovis buys orthopedic bracing assets of Outcome-Based Technologies

May 31, 2022 By Danielle Kirsh

Enovis (NYSE:ENOV) recently announced that its subsidiary DJO Global acquired the assets of Outcome-Based Technologies hip and knee bracing portfolio. DJO added the Excyabir hip brace and CryoKnee knee braces to its DonJoy bracing brand. The financial terms of the deal were not disclosed. “The acquisition of the Excyabir hip brace and the CryoKnee knee […]

Filed Under: Business/Financial News, Featured, Mergers & Acquisitions, News Well, Orthopedics Tagged With: DJO, Enovis, Outcome-Based Technologies

Si-Bone wins FDA clearance for pelvic fixation, fusion tech

May 31, 2022 By Sean Whooley

Si-Bone announced today that it received FDA 510(k) clearance for its iFuse Bedrock Granite implant system for spinal procedures. Santa Clara, California-based Si-Bone designed the iFuse “Granite” implant to provide sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion. According to a news release, FDA clearance follows earlier breakthrough device designation […]

Filed Under: 510(k), Food & Drug Administration (FDA), Implants, News Well, Orthopedics, Regulatory/Compliance, Spine Tagged With: FDA, Si-Bone

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