Cleared Traditional

K212356 - Exactech® Equinoxe® Laser Cage Glenoid (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 189
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K212356.
AETOS Shoulder System - CONCELOC Glenoids
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K241292 · Medacta International S.A. · Jan 2025
Tornier Humeral Reconstruction System (Tornier HRS)
K241878 · Stryker Corporation (Tornier, Inc.) · Dec 2024
Tornier Humeral Reconstruction System (Tornier HRS)
K241609 · Stryker Corporation (Tornier, Inc.) · Sep 2024