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FDA drafts a guided PMA submission template and sets a November 17 comment deadline FDA keeps radiology AI on the 510(k) path and denies Harrison.ai's exemption petition FIZE Medical takes a first close on a $20M Series B with its Japanese distributor co-leading Emanate clears Perio PODS, an at-home hydrogel dressing for after scaling and root planing Wandercraft opens Eve exoskeleton sales with Medicare code K1007 in hand Medtronic clears a robotic LigaSure vessel sealer for Hugo, nine months after the robot FDA clears Neptune Medical's Triton 1 robotic colonoscope after a 50-patient study FDA takes pathogen-agnostic sequencing to an advisory panel on November 19 CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027 FDA drafts a guided PMA submission template and sets a November 17 comment deadline FDA keeps radiology AI on the 510(k) path and denies Harrison.ai's exemption petition FIZE Medical takes a first close on a $20M Series B with its Japanese distributor co-leading Emanate clears Perio PODS, an at-home hydrogel dressing for after scaling and root planing Wandercraft opens Eve exoskeleton sales with Medicare code K1007 in hand Medtronic clears a robotic LigaSure vessel sealer for Hugo, nine months after the robot FDA clears Neptune Medical's Triton 1 robotic colonoscope after a 50-patient study FDA takes pathogen-agnostic sequencing to an advisory panel on November 19 CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027

Clinical data

CurvaFix puts a 1.45 percent removal rate on its first 3,800 pelvic implants

MedDevice Startups Staff · 2 days ago · 2 min read · Via CurvaFix release

CurvaFix released real world numbers on its first 3,800 pelvic implants. More than 200 surgeons placed them. The removal rate was 1.45 percent.

Breakage in vivo came in at 0.03 percent, implant backout at 0.05 percent and malpositioning at 0.24 percent. Surgeons present the data at the Orthopaedic Trauma Association annual meeting in Nashville, which runs September 23 to 26. Seven published articles cover the technology in fragility fractures, trauma and oncology cases.

The company sells two 510(k) cleared systems from Kirkland, Washington: the CurvaFix IM System and a Low Profile System introduced at OTA 2025 with a head 65 percent smaller. A registry style count carries less weight than a controlled trial. For an implant company still building surgeon trust it is also the cheapest credible evidence available.

Questions & Answers

What removal rate did CurvaFix report for its pelvic implants?

CurvaFix reported a 1.45 percent removal rate across its first 3,800 implants, placed by more than 200 surgeons. The company released the figures on September 17, 2026.

What complication rates did CurvaFix report across 3,800 implants?

CurvaFix reported in vivo implant breakage of 0.03 percent, implant backout of 0.05 percent and implant malpositioning of 0.24 percent across its first 3,800 implants.

Which CurvaFix products have FDA clearance?

Both the CurvaFix IM System and the CurvaFix Low Profile System have 510(k) clearance. The Low Profile System, introduced at OTA 2025, has an implant head 65 percent smaller.

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