# K031337: Acumen Surgical Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Sep 15, 2003 after 140 days
- Product code: HAW (Neurological 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: 6 generations back to K905070 (1991). 15 ancestors in all.
81 later devices descend from it; 3 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023975: Voyager Linux, Z-Kat, Inc. (2002) Summary page 1.
- K013025: Modification to Flourolab Plus, Z-Kat, Inc. (2001) Summary page 1.

## Most influential descendants
- K072806: Mako Surgical Tactile Guidance System (TGS) (2008), 78 descendants of its own
- K081867: Mako Surgical Tactile Guidance System Version 2.0 (2008), 76 descendants of its own
- K112507: Restoris Partial Knee Application (Pka), Rio Standard System (2012), 46 descendants of its own
- K143752: Total Knee Application (TKA) (2015), 44 descendants of its own
- K170581: Mako Total Knee Application (2017), 38 descendants of its own

## Indications for use
The Acumen™ Surgical Navigation System is intended to assist the surgeon in providing orientation and reference information to anatomical structures during open or percutaneous orthopedic procedures. The Acumen™ System is indicated for use in surgical knee and trauma procedures, in which the use of stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT or MRI biased model, fluoroscopy or an imageless model of the anatomy. These procedures include, but are not limited to knee arthroplasty or trauma reconstructive procedure:;.

Source page: https://510kreport.com/device/K031337
Methodology: https://510kreport.com/methodology