# K101909: Exactech Equinoxe, Platform Fracture Stem

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Aug 2, 2010 after 25 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K911686 (1991). 80 ancestors in all.
No later device cites it as a predicate yet.
1 of 81 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092900: Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture Stem, Exactech, Inc. (2010) Summary page 5.

## 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.
- Dec 3, 2019 · Class II · Z-0873-2020: Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the origin
- Dec 3, 2019 · Class II · Z-0872-2020: Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the origin

## Indications for use
The Equinoxe Shoulder System is indicated for use 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 for use 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 for use 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). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

Source page: https://510kreport.com/device/K101909
Methodology: https://510kreport.com/methodology