Cleared Traditional

K202815 - PROPHECY Preoperative Navigation Alignm...

K202815 is the FDA 510(k) clearance for PROPHECY Preoperative Navigation Alignm... by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code HSN) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K202815 · Wrightmedicaltechnologyinc · Orthopedic device
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Mar 2021
Decision
167d
Days
Class 2
Risk

K202815 is an FDA 510(k) clearance for the PROPHECY Preoperative Navigation Alignment System. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Bloomington, US). The FDA issued a Cleared decision on March 10, 2021 after a review of 167 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 K202815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 122d · This submission: 167d
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
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