# K212356: Exactech® Equinoxe® Laser Cage Glenoid

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Mar 4, 2022 after 218 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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: 10 generations back to K920362 (1993). 66 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113309: Exactech Equinoxe Cage Glenoids, Exactech, Inc. (2011) Summary page 7.
- K121220: Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right, Exactech, Inc. (2012) Summary page 7.
- K111379: Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large / Extra-Large, Left / Right, Exactech, Inc. (2011) Summary page 7.

## Most influential descendants
- K254084: AETOS Shoulder System - CONCELOC Glenoids (2026), 0 descendants of its own
- K231099: SMR Hybrid Glenoid System (2023), 0 descendants of its own

## Recalls of this device
- Nov 21, 2023 · Class II · Z-0580-2024: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

## 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. • The cemented primary humeral stem, long/revision stem, fracture stems, and all Equinoxe glenoids are intended for cemented fixation. • The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion the surgeon. • The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon. • Humeral Heads are intended for use in cemented and press-fit applications. Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows: P L F Indications √ √ 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 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) √ 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/K212356
Methodology: https://510kreport.com/methodology