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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 / K261683

510(k) cleared

Augment Off-Axis Instrument System

Zimmer, Inc. · Jun 16, 2026 · K261683

FDA cleared the Augment Off-Axis Instrument System from Zimmer, Inc. on Jun 16, 2026 under K261683, a special 510(k). The device falls under product code PHX, Shoulder Prosthesis, Reverse Configuration, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on May 21, 2026. The decision came 26 days later, inside the 90 FDA-day goal for a 510(k).

Zimmer, Inc. has 7 other decisions in the tracker over the last 12 months: K260831 (Z1 Hip System), K251840 (Zimmer® Persona® Personalized Knee System), K260182 (Avenir® Müller Stem; Avenir Complete Hip System), K253592 (Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)).

Questions & Answers

What did FDA clear under K261683?

K261683 is the FDA 510(k) for Augment Off-Axis Instrument System, submitted by Zimmer, Inc.. FDA's decision date was Jun 16, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the Augment Off-Axis Instrument System?

Zimmer, Inc., based in Warsaw, IN, is the applicant of record for K261683.

How long did the K261683 review take?

FDA received the submission on May 21, 2026 and issued its decision on Jun 16, 2026, 26 days later.

← All decisions in June 2026