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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 / K253159

510(k) cleared

Prophecy Incompass Surgical Planning System

Wright Medical Technology, Inc. (Stryker) · Jun 16, 2026 · K253159

FDA cleared the Prophecy Incompass Surgical Planning System from Wright Medical Technology, Inc. (Stryker) on Jun 16, 2026 under K253159, a traditional 510(k). The device falls under product code HSN, Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer, regulated at 21 CFR 888.3110 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 26, 2025. The decision came 263 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Wright Medical Technology, Inc. (Stryker) has 2 other decisions in the tracker over the last 12 months: K251643 (Synchfix EVT), K252085 (Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)).

Questions & Answers

What did FDA clear under K253159?

K253159 is the FDA 510(k) for Prophecy Incompass Surgical Planning System, submitted by Wright Medical Technology, Inc. (Stryker). FDA's decision date was Jun 16, 2026, under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer).

Who makes the Prophecy Incompass Surgical Planning System?

Wright Medical Technology, Inc. (Stryker), based in Memphis, TN, is the applicant of record for K253159.

How long did the K253159 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jun 16, 2026, 263 days later.

← All decisions in June 2026

Sources