Cleared Traditional

K153008 - INVISION Total Ankle Revision System

K153008 is an FDA 510(k) clearance for INVISION Total Ankle Revision System, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HSN cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K153008 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
205d
Days
Class 2
Risk

K153008 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 May 6, 2016 after a review of 205 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

FDA 510(k) Submission Details - K153008

510(k) Number K153008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2015
Decision Date May 06, 2016
Days to Decision 205 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
83d slower than avg
Panel avg: 122d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSN Device Classification - Class 2, Special Controls

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 65
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K153008.
PROPHECY INVISION Pre-operative Navigation System
K170968 · Wrightmedicaltechnologyinc · Aug 2017
PROPHECY INVISION Preoperative Navigation Alignment System
K162795 · Wrightmedicaltechnologyinc · Feb 2017
Salto XT, Salto Talaris
K153452 · Tornier S.A.S. · Aug 2016
Exactech Vantage Total Ankle System
K152217 · Exactech, Inc. · Mar 2016
Integra Total Ankle Replacement System
K151459 · Ascension Orthopedics · Aug 2015
INVISION TOTAL ANKLE REVISION SYSTEM
K142117 · Wrightmedicaltechnologyinc · Mar 2015