From navigation tools to surgery systems, here are eight orthopedic and spine systems, devices and implants that have received FDA clearance, as reported by Becker’s since April 27:
Spinal Tech
Amplio Spine has finalized its acquisition of the KeyLift expandable interlaminar stabilization system from FloSpine and launched national commercialization of the device. The transaction included KeyLift’s intellectual property portfolio, FDA 510(k) clearance, finished inventory and distributor relationships. Financial terms were…
Mighty Oak Medical’s Acorn 3D pre-surgical correction planning software earned FDA clearance, the company said in a June 16 LinkedIn post. Acorn 3D uses AI-driven automated scan segmentation and pre-correction measurements to support spinal deformity correction planning. The software leverages…
Elevation Spine’s Saber-C ACDF implant has surpassed 5,000 implantations, the company said June 16. The Saber-C system blends the stability of traditional anterior cervical plating with a streamlined workflow using the company’s proprietary Saber in-line spike fixation, according to a…
SurGenTec earned FDA 510(k) clearance for its ION-L lumbar facet fixation system, according to a June 15 news release. ION-L is a zero-profile implant designed for posterior lumbar facet fusion in patients with degenerative disc disease from L3 to S1…
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Rebecca Whitney, CEO of Highridge Medical, is stepping down to pursue a new CEO opportunity outside the spine industry, she said in a June 11 LinkedIn post. Ms. Whitney has led Highridge since April 2024. Before that she was global…
Some spine and orthopedic technologies are more hype, but others are showing clear improvements in processes and outcomes. Spine surgeon Brian Gantwerker, MD, and orthopedic surgeon Brian Nwannunu, MD, discussed the technologies that are proving themselves the most on a…
The number of breakthrough device designations granted by the FDA has seen a gradual increase and peaked in recent years, according to new data. The breakthrough device designation provides sped-up processes for development, assessment and review for clearance for selected…
Xenix Medical earned FDA 510(k) clearance for its Lux expandable lumbar interbody fusion system, and the device is available in a full commercial launch. The Lux system allows for significant post-expansion bone graft packing and features Xenix Medical’s NanoActiv surface,…
On the heels of strong sales in fiscal year 2026, Medtronic is placing high expectations on its new robotic system, leaders said in a June 3 earnings call. Rollout of Medtronic’s Stealth AXiS robot is going well with positive physician…