Cleared Traditional

K171067 - INVISION Total Ankle Revision System

K171067 is the FDA 510(k) clearance for INVISION Total Ankle Revision System by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code HSN) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K171067 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
154d
Days
Class 2
Risk

K171067 is an FDA 510(k) clearance for the INVISION Total Ankle Revision System. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on September 11, 2017 after a review of 154 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3110 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K171067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2017
Decision Date September 11, 2017
Days to Decision 154 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3110
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

All 58
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K171067.
INFINITY Total Ankle System
K181557 · Wrightmedicaltechnologyinc · Aug 2018
INVISION Total Ankle Revision System
K180730 · Wrightmedicaltechnologyinc · Jul 2018
INFINITY Total Ankle System
K172633 · Wrightmedicaltechnologyinc · Apr 2018
PROPHECY INVISION Pre-operative Navigation System
K170968 · Wrightmedicaltechnologyinc · Aug 2017
PROPHECY INVISION Preoperative Navigation Alignment System
K162795 · Wrightmedicaltechnologyinc · Feb 2017
INVISION Total Ankle Revision System
K153008 · Wrightmedicaltechnologyinc · May 2016