# K241043: Augment Off-Axis Instrument System

- Pathway: 510(k) (Special)
- Applicant: Fix Surgical
- Decided: May 15, 2024 after 28 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K911686 (1991). 92 ancestors in all.
1 later device descends 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)
- K233148: Augment Off-Axis Instrument System, Fix Surgical (2024) Summary page 4.

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

## Recalls of this device
- May 20, 2026 · Class II · Z-2528-2026: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- May 20, 2026 · Class II · Z-2531-2026: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- May 20, 2026 · Class II · Z-2530-2026: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- May 20, 2026 · Class II · Z-2529-2026: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- May 20, 2026 · Class II · Z-2527-2026: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

## 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/K241043
Methodology: https://510kreport.com/methodology