# K231229: S-COMP Reform® POCT Navigation Instruments

- Pathway: 510(k) (Special)
- Applicant: Precision Spine, Inc.
- Decided: May 25, 2023 after 27 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: 13 generations back to K862807 (1986). 68 ancestors in all.
No later device cites it as a predicate yet.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181111: Navigated INFINITY Instruments, Medtronic Sofamor Danek USA, Inc. (2018) Summary page 4.
- K181606: Precision Spine Navigation Instrumentation, Precision Spine, Inc. (2019) Summary page 4.

## Indications for use
Precision Spine S-COMP Reform® POCT Navigated Instruments are indicated for use during the preparation and placement of Precision Spine Reform® POCT Polyaxial Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The navigated instruments are reusable and are specifically designed for use with the Medtronic StealthStation® System which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Use of the S-COMP Reform® POCT Navigated Instruments with the Medtronic StealthStation® System is limited to use with the Reform® POCT Spinal Fixation System when the correct Infinity™ tool cards are selected.

Source page: https://510kreport.com/device/K231229
Methodology: https://510kreport.com/methodology