Cleared Traditional

K212356 - Exactech® Equinoxe® Laser Cage Glenoid

K212356 is an FDA 510(k) clearance for Exactech Equinoxe Laser Cage Glenoid, manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K212356 · Exactech, Inc. · Orthopedic device
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Mar 2022
Decision
218d
Days
Class 2
Risk

K212356 is an FDA 510(k) clearance for the Exactech® Equinoxe® Laser Cage Glenoid. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on March 4, 2022 after a review of 218 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 Exactech, Inc. devices

FDA 510(k) Submission Details - K212356

510(k) Number K212356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2021
Decision Date March 04, 2022
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
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 183
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K212356.
AltiVate® Anatomic Shoulder AG e+™ with Markers
K213387 · Encore Medical, L.P. · Jul 2022
SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid
K213785 · Limacorporate · May 2022
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
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
Augmented VaultLock Glenoid
K210050 · Arthrex, Inc. · Jun 2021