Cleared Traditional

K172210 - ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

K172210 is an FDA 510(k) clearance for ReUnion Reversible Fracture System (RFX), manufactured by Stryker Trauma AG. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K172210 · Stryker Trauma AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
70d
Days
Class 2
Risk

K172210 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 Trauma AG (Mahwah, US). The FDA issued a Cleared decision on October 2, 2017 after a review of 70 days - a notably fast clearance 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: 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 - K172210

510(k) Number K172210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2017
Decision Date October 02, 2017
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWS Device Classification - Class 2, Special Controls

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 186
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K172210.
Arthrex Shoulder System
K171841 · Arthrex, Inc. · Mar 2018
Materialise Glenoid Positioning System
K172054 · Materialise NV · Nov 2017
AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert
K172351 · Encore Medical, L.P. · Oct 2017
Medacta Anatomic Shoulder Prosthesis
K170910 · Medacta International S.A. · Aug 2017
Materialise Glenoid Positioning System
K170893 · Materialise NV · Jun 2017
BLUEPRINT Patient Specific Instrumentation
K162800 · Tornier S.A.S. · Feb 2017