Cleared Traditional

K241999 - Prophecy Surgical Planning System

K241999 is an FDA 510(k) clearance for Prophecy Surgical Planning System, manufactured by Wright Medical Technology, Inc. (Stryker). The device is a Class 2 Orthopedic device with product code HSN cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K241999 · Wright Medical Technology, Inc. (Stryker) · Orthopedic device
Download Printable Device Report (PDF)
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Nov 2024
Decision
115d
Days
Class 2
Risk

K241999 is an FDA 510(k) clearance for the Prophecy Surgical Planning System. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Wright Medical Technology, Inc. (Stryker) (Memphis, US). The FDA issued a Cleared decision on November 1, 2024 after a review of 115 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 Wright Medical Technology, Inc. (Stryker) devices

FDA 510(k) Submission Details - K241999

510(k) Number K241999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2024
Decision Date November 01, 2024
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
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 58
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K241999.
Incompass Total Ankle System
K250037 · Wright Medical Technology, Inc. (Stryker) · Jun 2025
APEX 3D Total Ankle Replacement System
K250641 · Paragon 28, Inc. · May 2025
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K240475 · Vilex, LLC · Dec 2024
Kinos Total Ankle System
K242868 · Restor3d · Oct 2024
Kinos Total Ankle System
K241482 · Restor3d · Jul 2024
APEX 3D Total Ankle Replacement System
K240259 · Paragon 28, Inc. · Jun 2024