# K161878: PORTAGE System

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Company, Inc.
- Decided: Sep 26, 2016 after 80 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002931 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002931: Metrx System, Medtronic Sofamor Danek, Inc. (2000) Summary page 4.

## Indications for use
The PORTAGE System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the PORTAGE Endoscope and accessories are intended to aid the surgeon’s visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants. Other examples of generic surgical use of the PORTAGE System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

Source page: https://510kreport.com/device/K161878
Methodology: https://510kreport.com/methodology