Cleared Traditional

K251643 - Synchfix EVT

K251643 is an FDA 510(k) clearance for Synchfix EVT, manufactured by Wright Medical Technology, Inc. (Stryker Corporation). The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K251643 · Wright Medical Technology, Inc. (Stryker Corporation) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
153d
Days
Class 2
Risk

K251643 is an FDA 510(k) clearance for the Synchfix EVT. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Wright Medical Technology, Inc. (Stryker Corporation) (Memphis, US). The FDA issued a Cleared decision on October 29, 2025 after a review of 153 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Corporation) devices

FDA 510(k) Submission Details - K251643

510(k) Number K251643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2025
Decision Date October 29, 2025
Days to Decision 153 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
31d slower than avg
Panel avg: 122d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTN Device Classification - Class 2, Special Controls

Product Code HTN Washer, Bolt Nut
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HTN Washer, Bolt Nut

All 69
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K251643.
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