# K160385: Precision Screw

- Pathway: 510(k) (Traditional)
- Applicant: Cryptych Pty, Ltd.
- Decided: Jul 27, 2016 after 167 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 K854886 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010427: Lorenz Fiducail Screw, Walter Lorenz Surgical, Inc. (2001) Summary page 4.

## Indications for use
The Precision Screw is intended for establishing fixed reference point(s) in patients undergoing Stereotactic Surgery for procedures in the cortical bone of the vertebrae. The Precision Screw can be used as an accessory with frameless navigation systems.

Source page: https://510kreport.com/device/K160385
Methodology: https://510kreport.com/methodology