Cleared Traditional

K213328 - Gamma4 System

K213328 is the FDA 510(k) clearance for Gamma4 System by Stryker GmbH. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K213328 · Stryker GmbH · Orthopedic device
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Feb 2022
Decision
129d
Days
Class 2
Risk

K213328 is an FDA 510(k) clearance for the Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Stryker GmbH (Mahwah, US). The FDA issued a Cleared decision on February 11, 2022 after a review of 129 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 GmbH devices

Submission Details

510(k) Number K213328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2021
Decision Date February 11, 2022
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
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 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K213328.
AUTOBAHN(R) EVO Femoral Nails
K220659 · Globus Medical, Inc. · Sep 2022
Pediatric Nailing Platform Femur
K220679 · OrthoPediatrics Corp. · Jul 2022
Flow-Nail
K221115 · Flow-Fx, LLC · May 2022
GPC Intraheal Intramedullary Nailing System
K203811 · Gpc Medical Limited · Feb 2022
The Progen™ Trochanteric Nail System
K211086 · Ortho Development Corporation · Dec 2021
Flex-Thread™ Distal Fibula lntramedullary Nail System
K212030 · Flower Orthopedics Corporation Dba Conventus Flower · Jul 2021