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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 / August 2026 / K261563

510(k) cleared

Freedom Total Knee System (E-Poly Tibial Liners)

Maxx Orthopedics, Inc. · Aug 7, 2026 · K261563

FDA cleared the Freedom Total Knee System (E-Poly Tibial Liners) from Maxx Orthopedics, Inc. on Aug 7, 2026 under K261563, a traditional 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 May 11, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

Maxx Orthopedics, Inc. has 4 other decisions in the tracker over the last 12 months: K253171 (Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)), K252777 (Freedom Metaphyseal Cone Implants (Metaphyseal Cones)), K253314 (Freedom Infinia Total Knee System), K253144 (Freedom® Total Knee System Titan PCK Components).

Questions & Answers

What did FDA clear under K261563?

K261563 is the FDA 510(k) for Freedom Total Knee System (E-Poly Tibial Liners), submitted by Maxx Orthopedics, Inc.. FDA's decision date was Aug 7, 2026, under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Who makes the Freedom Total Knee System (E-Poly Tibial Liners)?

Maxx Orthopedics, Inc., based in Norristown, PA, is the applicant of record for K261563.

How long did the K261563 review take?

FDA received the submission on May 11, 2026 and issued its decision on Aug 7, 2026, 88 days later.

← All decisions in August 2026

Sources