LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250713

    Validate with FDA (Live)

    Device Name
    Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
    Manufacturer
    Exactech, Inc.
    Date Cleared
    2025-12-01

    (266 days)

    Product Code
    KWT,HSD,KWS,PHX,PKC
    Regulation Number
    888.3650
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K143659,K162903,K173388,K192097
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Humeral Reconstruction Prosthesis

    The Equinoxe® Humeral Reconstruction Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:

    • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
    • Rheumatoid arthritis
    • Revision where other devices or treatments have failed
    • Correction of functional deformity
    • Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
    • Traumatic arthritis
    • Oncology applications including bone loss due to tumor resection.
    • Significant humeral resection which are unmanageable using other treatment methods

    The Equinoxe® Humeral Reconstruction Prosthesis System can be used in either primary or revision arthroplasty procedures.

    The Equinoxe® Humeral Reconstruction Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreplaceable and grossly deficient, and a functional deltoid muscle is present.

    In the USA, the Equinoxe® Humeral Reconstruction Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.

    The Equinoxe® Humeral Reconstruction Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe® Humeral Reconstruction Prosthesis Distal Stem Collars are only for uncemented, press-fit use.

    Stemless Shoulder

    The Equinoxe® Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. Clinical indications for anatomic total shoulder arthroplasty are as follows:

    • Osteoarthritis, osteonecrosis or post-traumatic degenerative problems.
    • Congenital abnormalities in the skeletally mature.
    • Primary and secondary necrosis of the humeral head.
    • Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable.
    • Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved).
    • To restore mobility from previous procedures (e.g. previous fusion).

    The Equinoxe® Stemless Shoulder humeral components are indicated for press-fit, uncemented use.

    The Equinoxe® Stemless Shoulder System is intended to be used with the cemented Equinoxe® glenoid components.

    Device Description

    Humeral Reconstruction Prosthesis

    The Exactech Equinoxe Humeral Reconstruction Prosthesis is designed to replace both the articulating surface of the shoulder (humeral head) as well as resected humerus. The modular design of the system allows for a surgeon to construct the middle and proximal segments of the prosthesis in various lengths in order to match the length of resected bone and maintain the natural arm length of the patient.

    The prosthesis is manufactured from Ti-6Al-4V and has both Titanium Plasma Spray and HA coated regions. The proximal bodies are available in five sizes (Extra-Small, Small, Medium, Large, Extra-Large) and two lengths (+0mm, +12.5mm). The middle segments are available in 3 lengths (25mm, 50mm, 75mm) with one diameter. The distal stems are available in 3 lengths (80mm, 120mm, 200mm) and 6 diameters (6mm, 7mm, 8mm, 9mm, 11mm, 13mm). The distal stem collars are available in 17 diameters (17.5mm-33.5mm, 1mm increments). The distal stem collars are intended for press-fit fixation. The proximal bodies and middle segments have suture throughholes to facilitate soft tissue attachment.

    Stemless Shoulder

    The Equinoxe Stemless Shoulder is intended to be used with Exactech glenoid components for use in Total Shoulder Arthroplasty. The Equinoxe Stemless Shoulder includes humeral components and humeral heads. The Equinoxe Stemless Humeral Components are additively manufactured from Titanium Alloy and have porous regions. The Stemless Humeral Heads are made from Cobalt Chrome Alloy. The Equinoxe Stemless Humeral Components are available in 3 sizes, and the Stemless Humeral Heads are available in available in 12 sizes, with diameters between 36mm and 53mm and two height options (Extra Short, Short).

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1