Cleared Traditional

K250037 - Incompass Total Ankle System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250037 · Wright Medical Technology, Inc. (Stryker) · Orthopedic device
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Jun 2025
Decision
163d
Days
Class 2
Risk

K250037 is an FDA 510(k) clearance for the Incompass Total Ankle 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 June 20, 2025 after a review of 163 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 Wright Medical Technology, Inc. (Stryker) devices

Submission Details

510(k) Number K250037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2025
Decision Date June 20, 2025
Days to Decision 163 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
41d slower than avg
Panel avg: 122d · This submission: 163d
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 66
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K250037.
Kinos Total Ankle System
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K240475 · Vilex, LLC · Dec 2024
Prophecy Surgical Planning System
K241999 · Wright Medical Technology, Inc. (Stryker) · Nov 2024
Kinos Total Ankle System
K242868 · Restor3d · Oct 2024
Kinos Total Ankle System
K241482 · Restor3d · Jul 2024