Cleared Traditional

K123401 - GAMMA3 AND T2 RECON TARGETING DEVICES

K123401 is an FDA 510(k) clearance for GAMMA3 AND T2 RECON TARGETING DEVICES, manufactured by Stryker Trauma AG. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K123401 · Stryker Trauma AG · Orthopedic device
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Jan 2013
Decision
79d
Days
Class 2
Risk

K123401 is an FDA 510(k) clearance for the GAMMA3 AND T2 RECON TARGETING DEVICES. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Stryker Trauma AG (Mahwah, US). The FDA issued a Cleared decision on January 23, 2013 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Trauma AG devices

FDA 510(k) Submission Details - K123401

510(k) Number K123401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2012
Decision Date January 23, 2013
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

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 365
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K123401.
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K122170 · Smith & Nephew, Inc. · Oct 2012
AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW
K120148 · Advanced Orthopaedic Solutions, Inc. · Oct 2012
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
K120715 · Zimmer GmbH · Aug 2012