Cleared Traditional

K170968 - PROPHECY INVISION Pre-operative Navigation System

K170968 is an FDA 510(k) clearance for PROPHECY INVISION Pre-operative Navigat..., manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HSN cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K170968 · Wrightmedicaltechnologyinc · Orthopedic device
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Aug 2017
Decision
138d
Days
Class 2
Risk

K170968 is an FDA 510(k) clearance for the PROPHECY INVISION Pre-operative Navigation 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 August 16, 2017 after a review of 138 days - within the typical 510(k) review window.

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 - K170968

510(k) Number K170968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2017
Decision Date August 16, 2017
Days to Decision 138 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
16d slower than avg
Panel avg: 122d · This submission: 138d
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 K170968.
INFINITY Total Ankle System
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K171004 · Dt Medtech, LLC · Nov 2017
INVISION Total Ankle Revision System
K171067 · Wrightmedicaltechnologyinc · Sep 2017
PROPHECY INVISION Preoperative Navigation Alignment System
K162795 · Wrightmedicaltechnologyinc · Feb 2017
Salto XT, Salto Talaris
K153452 · Tornier S.A.S. · Aug 2016
INVISION Total Ankle Revision System
K153008 · Wrightmedicaltechnologyinc · May 2016