Cleared Traditional

K210050 - Augmented VaultLock Glenoid

K210050 is an FDA 510(k) clearance for Augmented VaultLock Glenoid, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K210050 · Arthrex, Inc. · Orthopedic device
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Jun 2021
Decision
150d
Days
Class 2
Risk

K210050 is an FDA 510(k) clearance for the Augmented VaultLock Glenoid. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on June 7, 2021 after a review of 150 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 Arthrex, Inc. devices

FDA 510(k) Submission Details - K210050

510(k) Number K210050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2021
Decision Date June 07, 2021
Days to Decision 150 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
28d slower than avg
Panel avg: 122d · This submission: 150d
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 184
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K210050.
Exactech® Equinoxe® Laser Cage Glenoid
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Comprehensive Humeral Fracture Positioning Sleeves
K212435 · Biomet, Inc. · Dec 2021
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
K210861 · Stryker GmbH · Sep 2021
BLUEPRINT™ Patient Specific Instrumentation
K203315 · Tornier S.A.S. · Apr 2021
Global Shoulder and Delta CTA systems
K203230 · Depuy Lnc. · Apr 2021
AltiVate® Anatomic Pegged Glenoid with Markers
K203026 · Encore Medical, L.P. · Dec 2020