# K162726: Exactech® Equinoxe® Preserve Stem

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Feb 1, 2017 after 125 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 1 (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). 73 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 77 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060692: Comprehensive Primary Shoulder Stems, Biomet Manufacturing Corp (2006) Summary page 4.
- K042021: Exactech Equinoxe Shoulder System, Exactech, Inc. (2004) Summary page 4.
- K080642: Comprehensive Reverse Shoulder, Biomet, Inc. (2008) Summary page 4.

## Most influential descendants
- K202024: ARROW Short Stem Humeral System (2021), 2 descendants of its own
- K253345: JARVIS Diaphyseal Stem Standard (2025), 1 descendant of its own
- K254003: JARVIS Metaphyseal Stem (2026), 0 descendants of its own

## Recalls of this device
- Dec 5, 2018 · Class II · Z-0958-2019: Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as inten

## Indications for use
The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty, anatomic hemi-arthroplasty, or reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment. Clinical indications for anatomic total arthroplasty and anatomic hemi-arthroplasty 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. • 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 Preserve Stems are additionally indicated for use in reverse total arthroplasty in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff or a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Equinoxe Preserve Stems are intended for press-fit applications but may be used with bone cement at the discretion of the surgeon.

Source page: https://510kreport.com/device/K162726
Methodology: https://510kreport.com/methodology