Cleared Traditional

K131298 - EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM

K131298 is an FDA 510(k) clearance for EXACTECH EQUINOXE RESURFACING HUMERAL H..., manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K131298 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K131298

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.

HSD Device Classification - Class 2, Special Controls

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 65
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K131298.
Anatomical Shoulder Domelock Dome centric
K161620 · Zimmer GmbH · Nov 2016
Arthrex Univers Revers CA Heads and Adapters
K151527 · Arthrex, Inc. · Apr 2016
HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System
K142942 · Arthrosurface, Inc. · Dec 2014
HUMELOCK II CEMENTLESS SHOULDER SYSTEM
K130759 · Fx Solutions · Nov 2013
ARTHREX UNIVERS II CA HEADS
K130675 · Arthrex, Inc. · Oct 2013
SEVIIN SURFACE REPLACEMENT SHOULDER
K130635 · Ingen Orthopedics, LLC · Aug 2013