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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 Tracker / June 2026 / K243192

510(k) cleared

iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating

Nextstep Arthopedix, LLC · Jun 5, 2026 · K243192

FDA cleared the iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating from Nextstep Arthopedix, LLC on Jun 5, 2026 under K243192, a traditional 510(k). The device falls under product code LPH, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, regulated at 21 CFR 888.3358 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 30, 2024. The decision came 613 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Nextstep Arthopedix, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243192?

K243192 is the FDA 510(k) for iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating, submitted by Nextstep Arthopedix, LLC. FDA's decision date was Jun 5, 2026, under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented).

Who makes the iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating?

Nextstep Arthopedix, LLC, based in Akron, OH, is the applicant of record for K243192.

How long did the K243192 review take?

FDA received the submission on Sep 30, 2024 and issued its decision on Jun 5, 2026, 613 days later.

← All decisions in June 2026