Cleared Traditional

EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM (K131298) - FDA 510(k) Clearance

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

K131298 · Exactech, Inc. · Orthopedic device
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Nov 2013
Decision
204d
Days
Class 2
Risk

K131298 is an FDA 510(k) clearance for the EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on November 26, 2013 after a review of 204 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3690 - 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 K131298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2013
Decision Date November 26, 2013
Days to Decision 204 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
82d slower than avg
Panel avg: 122d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3690
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 - HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

All 32
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K131298.
OVOMotion Shoulder Arthroplasty System
K173964 · Arthrosurface, Inc. · Apr 2018
Arthrex Univers Revers Shoulder Prosthesis System
K161782 · Arthrex, Inc. · Nov 2016
Arthrex Univers Revers CA Heads and Adapters
K151527 · Arthrex, Inc. · Apr 2016
ARTHREX UNIVERS II CA HEADS
K130675 · Arthrex, Inc. · Oct 2013
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
K121714 · Smith & Nephew, Inc. · Sep 2012
DEPUY GLOBAL AP CTA HUMERAL HEAD
K082715 · DePuy Orthopaedics, Inc. · Dec 2008