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THE TAPE
Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register
The Directory // Orthopedics & Spine

Orthopedics & Spine

Implants, biologics, spine hardware and sports medicine. 6 companies listed.

eCential Robotics
Grenoble, France  ·  Est. 2009  ·  Acquired  ·  510(k) cleared

Builds the Op.n surgical platform, which combines 2D and 3D imaging, navigation and robotic guidance for spine and orthopedic procedures, and is open to third party implants and applications. Enovis agreed to acquire the company in September 2026.

Profile →www.ecential-robotics.com ↗
Empirical Spine
San Carlos, CA  ·  Series B  ·  PMA approved

Empirical Spine makes LimiFlex, a tension band implanted after lumbar decompression to stabilize the segment without fusion. The device came out of Stanford Biodesign and has a 2009 CE mark.

Profile →www.limiflex.com ↗
Meduloc
West Chester, PA  ·  Est. 2016  ·  Series B  ·  510(k) cleared

Makes a flexible nitinol intramedullary implant for long-bone fracture fixation in adults and children. Cleared under K250316 in October 2025 and in a controlled alpha launch.

Profile →www.meduloc.com ↗
MiRus
Marietta, GA  ·  Est. 2016  ·  Growth  ·  510(k) cleared

Builds spine and orthopedic implants from molybdenum-rhenium alloys, with 24 510(k) clearances, and is developing SIEGEL, a nickel-free balloon-expandable TAVR valve in the STAR trial. Boston Scientific owns about 34% after a $1.5B investment in May 2026.

Profile →www.mirusmed.com ↗
Synergy Spine Solutions
Louisville, CO  ·  Series A  ·  PMA approved

Synergy Spine Solutions makes the Synergy Disc, a cervical artificial disc with a lordotic core meant to restore alignment while preserving motion. It has sold outside the US since 2009.

Profile →synergyspinesolutions.com ↗
TYBR Health
Houston, TX  ·  Est. 2020  ·  Unknown

Makes a hydrogel coating applied to tendons during surgery to limit internal scarring after tendon and ligament repair.

Profile →www.tybrhealth.com ↗
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