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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 / May 2026 / K251270

510(k) cleared

Taperloc® Complete Hip Stem

Biomet, Inc. · May 19, 2026 · K251270

FDA cleared the Taperloc® Complete Hip Stem from Biomet, Inc. on May 19, 2026 under K251270, 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 Apr 24, 2025. The decision came 390 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Biomet, Inc. has one other decision in the tracker over the last 12 months: K253434 (OSSTM Orthopedic Salvage System).

Questions & Answers

What did FDA clear under K251270?

K251270 is the FDA 510(k) for Taperloc® Complete Hip Stem, submitted by Biomet, Inc.. FDA's decision date was May 19, 2026, under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented).

Who makes the Taperloc® Complete Hip Stem?

Biomet, Inc., based in Warsaw, IN, is the applicant of record for K251270.

How long did the K251270 review take?

FDA received the submission on Apr 24, 2025 and issued its decision on May 19, 2026, 390 days later.

← All decisions in May 2026

Sources