# K092900: Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture Stem

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Jan 7, 2010 after 108 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K911686 (1991). 79 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 82 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042021: Exactech Equinoxe Shoulder System, Exactech, Inc. (2004) Summary page 5.
- K073688: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw, Exactech, Inc. (2008) Summary page 5.
- K062029: Anatomical Shoulder Fracture System, Zimmer GmbH (2006) Summary page 5.
- K023063: Comprehensive Humeral Fracture System, Biomet Orthopedics, Inc. (2002) Summary page 5.
- K080642: Comprehensive Reverse Shoulder, Biomet, Inc. (2008) Summary page 5.
- K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System, Tornier (2006) Summary page 5.
- K071948: Aequalis Reversed Adapter, Tornier (2007) Summary page 5.

## Most influential descendants
- K131277: Seviin Fracture Shoulder (2013), 0 descendants of its own
- K101909: Exactech Equinoxe, Platform Fracture Stem (2010), 0 descendants of its own

## Recalls of this device
- Sep 25, 2020 · Class II · Z-0307-2021: The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
- Sep 25, 2020 · Class II · Z-0308-2021: The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.

## Indications for use
The Equinoxe Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment. Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows: Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems Congenital abnormalities in the skeletally mature Primary and secondary necrosis of the humeral head. Humeral head fracture with displacement of the tuberosities Pathologies where arthodesis 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) Displaced three-part and four-part upper humeral fractures Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases) Revision of failed previous reconstructions when distal anchorage is required To restore mobility from previous procedures (e.g. previous fusion) The Equinoxe Reverse Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The Equinoxe Platform Fracture Stem is indicated to relieve pain and restore function in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty).

Source page: https://510kreport.com/device/K092900
Methodology: https://510kreport.com/methodology