WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 Tracker / September 2025 / K252725

510(k) cleared

Stem Extension Line (U2 Total Knee SystemPSA Type)

United Orthopedic Corporation · Sep 25, 2025 · K252725

FDA cleared the Stem Extension Line (U2 Total Knee SystemPSA Type) from United Orthopedic Corporation on Sep 25, 2025 under K252725, a special 510(k). The device falls under product code JWH, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, regulated at 21 CFR 888.3560 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 28, 2025. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for United Orthopedic Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252725?

K252725 is the FDA 510(k) for Stem Extension Line (U2 Total Knee SystemPSA Type), submitted by United Orthopedic Corporation. FDA's decision date was Sep 25, 2025, under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Who makes the Stem Extension Line (U2 Total Knee SystemPSA Type)?

United Orthopedic Corporation, based in Kaohsiung, is the applicant of record for K252725.

How long did the K252725 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on Sep 25, 2025, 28 days later.

← All decisions in September 2025