Cleared Traditional

K250037 - Incompass Total Ankle System

K250037 is an FDA 510(k) clearance for Incompass Total Ankle 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 163-day FDA review.

K250037 · Wright Medical Technology, Inc. (Stryker) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K250037

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.

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 K250037.
Kinos Total Ankle System
K252454 · Restor3d · Sep 2025
APEX 3D Total Ankle Replacement System
K250641 · Paragon 28, Inc. · May 2025
Hintermann Series H2 Total Ankle System
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