Cleared Traditional

K200869 - Gamma3 System

K200869 is an FDA 510(k) clearance for Gamma3 System, manufactured by Stryker Trauma GmbH. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K200869

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.

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 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K200869.
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The Simple Locking Intramedullary (Slim) System
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