# K153700: Aesculap (R) Implant Systems (AIS) S4 Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, LLC
- Decided: Jul 8, 2016 after 198 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K853033 (1985). 47 ancestors in all.
No later device cites it as a predicate yet.
1 of 48 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130887: S4C Navigation Instruments, Aesculap Implant System, Inc. (2013) Summary page 5.

## Indications for use
The AIS S4 Navigation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutancous procedures. They are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion during the navigation of polyaxial screws (T1-T3).

Source page: https://510kreport.com/device/K153700
Methodology: https://510kreport.com/methodology