# K111843: Acufex Director Application Anatomic Guide System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Inc., Endoscopy Div.
- Decided: Nov 14, 2011 after 138 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: 3 generations back to K983831 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042512: Vectorvision Acl, Brainlab AG (2005) Summary page 3.

## Indications for use
The ACUFEX Director Application Anatomic Guide System is designed to help orthopedic surgeons and specialists access images intraoperative and provides user controlled visual feedback in order to assist in the planning and historical case review of the location of cruciate ligament tunnel insertion sites.

Source page: https://510kreport.com/device/K111843
Methodology: https://510kreport.com/methodology