Cleared Traditional

K250713 - Equinoxe® Humeral Reconstruction Prosthesis (FDA 510(k) Clearance)

Also includes:
Equinoxe® Stemless Shoulder Implants

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

K250713 · Exactech, Inc. · Orthopedic device
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Dec 2025
Decision
266d
Days
Class 2
Risk

K250713 is an FDA 510(k) clearance for the Equinoxe® Humeral Reconstruction Prosthesis. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on December 1, 2025 after a review of 266 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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 K250713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2025
Decision Date December 01, 2025
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 70
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K250713.
Tornier Humeral Reconstruction System Max (Tornier HRS Max)
K251686 · Tornier, Inc. · Oct 2025
AGILON® XO Shoulder Replacement System
K241944 · Implantcast GmbH · Mar 2025
InSet Total Shoulder System
K241817 · Shoulder Innovations, Inc. · Feb 2025
AGILON® XO Shoulder Replacement System
K231657 · Implantcast GmbH · Feb 2024
LINK Embrace Shoulder System- Anatomical Configuration
K210899 · Waldemar Link GmbH & Co. KG · Jun 2021