Cleared Traditional

Prophecy Preoperative Navigation Alignment System

K222835 · Wrightmedicaltechnologyinc · Orthopedic

Jan 2023

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K222835 is an FDA 510(k) clearance for the Prophecy Preoperative Navigation Alignment System, a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSN), submitted by Wrightmedicaltechnologyinc (Bloomington, US). The FDA issued a Cleared decision on January 27, 2023, 129 days after receiving the submission on September 20, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K222835 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2022
Decision Date	January 27, 2023
Days to Decision	129 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