Cleared Traditional

K250163 - T2 Alpha Femur Retrograde Nailing System (FDA 510(k) Clearance)

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

K250163 · Stryker GmbH · Orthopedic device
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Aug 2025
Decision
204d
Days
Class 2
Risk

K250163 is an FDA 510(k) clearance for the T2 Alpha Femur Retrograde Nailing System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Stryker GmbH (Selzach, Solothurn, Ch, CH). The FDA issued a Cleared decision on August 13, 2025 after a review of 204 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Stryker GmbH devices

Submission Details

510(k) Number K250163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2025
Decision Date August 13, 2025
Days to Decision 204 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
82d slower than avg
Panel avg: 122d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 522
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K250163.
AUTOBAHN™ Nailing System
K261043 · Globus Medical, Inc. · Apr 2026
Arthrex Humeral Nails
K252016 · Arthrex, Inc. · Mar 2026
Fusion FibFix Nail
K252961 · Fusion Orthopedics USA, LLC · Mar 2026
Affixus Retrograde Femoral Nailing System
K253566 · Zimmer, Inc. · Mar 2026
Reselute Tibial Nail
K253517 · Reselute, Inc. · Mar 2026
Arthrex FibuLock Nail System
K252196 · Arthrex, Inc. · Mar 2026