# K131298: Exactech Equinoxe Resurfacing Humeral Head System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Nov 26, 2013 after 204 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- 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). 27 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010657: Copeland MB Resurfacing Humeral Heads, Biomet Manufacturing, Inc. (2001)
- K062661: Aequalis Resurfacing Head, Tornier (2006) Summary page 1.
- K031971: Global Cap Resurfacing Replacement Shoulder, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K023096: Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System, Std Mfg., Inc. (2003) Summary page 1.

## Most influential descendants
- K152825: Catalyst CSR Shoulder System (2016), 7 descendants of its own
- K181287: Catalyst CSR Shoulder System (2018), 3 descendants of its own
- K182500: Catalyst CSR Press-Fit Humeral Components (2019), 2 descendants of its own
- K222317: Catalyst EA Convertible Stemmed Shoulder (2022), 1 descendant of its own
- K173812: Catalyst CSR 3 Peg Glenoids (2018), 1 descendant of its own

## Indications for use
The Equinoxe Resurfacing Humeral Head System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total arthroplasty is determined by the surgeon to be the preferred method of treatment. The Equinoxe Resurfacing Numeral Head System is intended for use in patients with the following conditions where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructahic. Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Post-traumatic Arthritis Correction of functional deformity Fractures of the humeral head The Equinoxe Resurfacing Humeral Head System is intended for uncemented use only.

Source page: https://510kreport.com/device/K131298
Methodology: https://510kreport.com/methodology