Cleared Traditional

K200869 - Gamma3 System

K200869 is the FDA 510(k) clearance for Gamma3 System by Stryker Trauma GmbH. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K200869 · Stryker Trauma GmbH · Orthopedic device
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Jul 2020
Decision
112d
Days
Class 2
Risk

K200869 is an FDA 510(k) clearance for the Gamma3 System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Stryker Trauma GmbH (Mahwah, US). The FDA issued a Cleared decision on July 22, 2020 after a review of 112 days - within the typical 510(k) review window.

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 Trauma GmbH devices

Submission Details

510(k) Number K200869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2020
Decision Date July 22, 2020
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
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 326
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K200869.
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Phantom® Hindfoot TTC/TC Nail System
K201227 · Paragon 28, Inc. · Jul 2020
T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System
K200880 · Stryker GmbH · Jul 2020
The Simple Locking Intramedullary (Slim) System
K192710 · Pega Medical, Inc. · Jun 2020