Cleared Traditional

K210861 - ReUnion Reversible Fracture System (RFX)

K210861 is the FDA 510(k) clearance for ReUnion Reversible Fracture System (RFX) by Stryker GmbH. It is a Class 2 Orthopedic device (product code KWS) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K210861 · Stryker GmbH · Orthopedic device
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Sep 2021
Decision
164d
Days
Class 2
Risk

K210861 is an FDA 510(k) clearance for the ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplas.... Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Stryker GmbH (Mahwah, US). The FDA issued a Cleared decision on September 3, 2021 after a review of 164 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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 K210861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2021
Decision Date September 03, 2021
Days to Decision 164 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
42d slower than avg
Panel avg: 122d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 152
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K210861.
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)
K213827 · Smith & Nephew, Inc. · Mar 2022
Exactech® Equinoxe® Laser Cage Glenoid
K212356 · Exactech, Inc. · Mar 2022
Comprehensive Humeral Fracture Positioning Sleeves
K212435 · Biomet, Inc. · Dec 2021
Augmented VaultLock Glenoid
K210050 · Arthrex, Inc. · Jun 2021
BLUEPRINT™ Patient Specific Instrumentation
K203315 · Tornier S.A.S. · Apr 2021
Global Shoulder and Delta CTA systems
K203230 · Depuy Lnc. · Apr 2021