Cleared Traditional

PROPHECY Preoperative Navigation Alignment System

K202815 · Wrightmedicaltechnologyinc · Orthopedic

Mar 2021

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K202815 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 March 10, 2021, 167 days after receiving the submission on September 24, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K202815 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2020
Decision Date	March 10, 2021
Days to Decision	167 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