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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 / July 2026 / K253434

510(k) cleared

OSSTM Orthopedic Salvage System

Biomet, Inc. · Jul 1, 2026 · K253434

FDA cleared the OSSTM Orthopedic Salvage System from Biomet, Inc. on Jul 1, 2026 under K253434, a traditional 510(k). The device falls under product code JDI, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, regulated at 21 CFR 888.3350 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Oct 1, 2025. The decision came 273 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: K251270 (Taperloc® Complete Hip Stem).

Questions & Answers

What did FDA clear under K253434?

K253434 is the FDA 510(k) for OSSTM Orthopedic Salvage System, submitted by Biomet, Inc.. FDA's decision date was Jul 1, 2026, under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented).

Who makes the OSSTM Orthopedic Salvage System?

Biomet, Inc., based in Warsaw, IN, is the applicant of record for K253434.

How long did the K253434 review take?

FDA received the submission on Oct 1, 2025 and issued its decision on Jul 1, 2026, 273 days later.

← All decisions in July 2026

Sources