# K223326: Axiom PSR System

- Pathway: 510(k) (Traditional)
- Applicant: Restor3D
- Decided: Mar 30, 2023 after 150 days
- Product code: OYK (Ankle Arthroplasty Implantation System)
- Device class: 2
- Regulation: 21 CFR 888.3110
- 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: 30 generations back to K841189 (1984). 568 ancestors in all.
No later device cites it as a predicate yet.
1 of 569 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193432: Vantage PSI System, 3D Systems (2020) Summary page 4.
- K192778: Kinos Axiom Total Ankle System, Kinos Medical (2020) Summary page 5.
- K220523: restor3d TiDAL Lumbar Interbody Fusion Device, Restor3D (2022) Summary page 5.

## Recalls of this device
- Jul 27, 2026 · Class II · Z-3178-2026: Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignm

## Indications for use
The Axiom PSR System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Axiom PSR System is intended for use with the Kinos Axiom Total Ankle System and its cleared indications for use.

Source page: https://510kreport.com/device/K223326
Methodology: https://510kreport.com/methodology