# K143659: Equinoxe Mega Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Apr 9, 2015 after 107 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K800494 (1980). 28 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111746: Comprehensive Segmental Revision System (SRS), Biomet, Inc. (2011) Summary page 4.

## Most influential descendants
- K173411: Comprehensive Segmental Revision System (SRS) (2018), 2 descendants of its own
- K223631: Comprehensive Segmental Revision System (SRS) (2023), 1 descendant of its own
- K162903: Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies (2017), 1 descendant of its own
- K250713: Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants (2025), 0 descendants of its own
- K251686: Tornier Humeral Reconstruction System Max (Tornier HRS Max) (2025), 0 descendants of its own

## Indications for use
The Equinoxe Mega 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 Mega Prosthesis System can be used in either primary or revision arthroplasty procedures. The Equinoxe Mega 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 irreparable and grossly deficient, and a functional deltoid muscle is present. The Equinoxe Mega Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications. The Equinoxe Mega Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Mega Prosthesis Distal Fixation Rings are only for uncemented, press-fit use.

Source page: https://510kreport.com/device/K143659
Methodology: https://510kreport.com/methodology