# K233148: Augment Off-Axis Instrument System

- Pathway: 510(k) (Traditional)
- Applicant: Fix Surgical
- Decided: Mar 22, 2024 after 177 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K911686 (1991). 91 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 94 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193373: Comprehensive® Reverse Shoulder, Biomet, Inc. (2020) Summary page 3.
- K080642: Comprehensive Reverse Shoulder, Biomet, Inc. (2008) Summary page 4.
- K193180: Alliance Augmented Glenoid, Zimmer, Inc. (2020) Summary page 3.

## Most influential descendants
- K241043: Augment Off-Axis Instrument System (2024), 1 descendant of its own
- K261683: Augment Off-Axis Instrument System (2026), 0 descendants of its own

## Indications for use
The Augment Off-Axis Instrument System consists of specialized instruments intended to prepare anatomy prior to implantation of Comprehensive® Reverse Shoulder System components in reverse total shoulder arthroplasty procedures or Alliance® Augmented Glenoid System components in anatomic total shoulder arthroplasty procedures in accordance with their respective cleared indications for use and contraindications. The instruments for this system are specifically indicated for use with the Comprehensive ® Reverse Shoulder System (K193373) or the Alliance® Augmented Glenoid System (K193180).

Source page: https://510kreport.com/device/K233148
Methodology: https://510kreport.com/methodology