Cleared Traditional

Prophecy Surgical Planning System

K241999 · Wright Medical Technology, Inc. (Stryker) · Orthopedic

Nov 2024

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K241999 is an FDA 510(k) clearance for the Prophecy Surgical Planning System, a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSN), submitted by Wright Medical Technology, Inc. (Stryker) (Memphis, US). The FDA issued a Cleared decision on November 1, 2024, 115 days after receiving the submission on July 9, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K241999 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 09, 2024
Decision Date	November 01, 2024
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSN — Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3110