# K141551: Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees) Suction, Profess Curved 90 (Degrees)

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporate
- Decided: Sep 8, 2014 after 89 days
- Product code: PGW (Ear, Nose, And Throat Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K993239 (2000). 5 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002732: Stryker  Navigation System - Ent Module, Stryker Corp. (2000) Summary page 6.
- K062640: Stryker Navigation System - Cranial Module, Model 6000-650-000, Stryker Instruments (2006) Summary page 6.
- K130874: Stryker NAV3I Platform, Stryker Corporate (2013) Summary page 6.

## Most influential descendants
- K153240: Styrker OrthoMap Express Knee System (2016), 17 descendants of its own
- K162341: Stryker OrthoMap Precision Knee system (2016), 16 descendants of its own
- K172034: Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap (2017), 12 descendants of its own
- K220593: Spine Guidance Software, Stryker Q Guidance System (2022), 10 descendants of its own
- K203205: Navigated Spine Instruments (2021), 8 descendants of its own

## Recalls of this device
- Mar 10, 2017 · Class II · Z-2071-2017: Product shipped proximate to or past the expiration date listed on the product label.

## Indications for use
The Stryker PROFESS™ system is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system tracks and displays the intraoperative location of navigated surgical instruments relative to a CT image. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The Stryker PROFESS™ system is indicated for intranasal and sinus surgery in which the use of computer-assisted surgery is appropriate and for which a CT image of the patient in accordance with the imaging protocol is available. The Stryker PROFESS™ system supports the following surgical procedures: • Endoscopic sinus surgery • Intranasal procedures

Source page: https://510kreport.com/device/K141551
Methodology: https://510kreport.com/methodology