# K050706: Harmony Port System, Model 1907 Series

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: Apr 15, 2005 after 28 days
- Product code: GZT (Retractor, Self-Retaining, For Neurosurgery)
- Device class: 2
- Regulation: 21 CFR 882.4800
- 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: 1 generation back to K992898 (1999). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992898: The Bright Medical Dilation Retractor System, Bright Medical Instruments (1999) Summary page 1.

## Most influential descendants
- K071771: Instrumed Retractors (2007), 2 descendants of its own
- K161004: Self-retaining Retractor (2016), 1 descendant of its own
- K161680: MEDICON Spinal Spreading Systems (2017), 0 descendants of its own

## Recalls of this device
- Dec 19, 2007 · Not classified · Z-0880-2008: Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use.

## Indications for use
To provide a self-locking mechanism to hold the edges of a wound open and allow for surgical exposure during general use and neurosurgical procedures.

Source page: https://510kreport.com/device/K050706
Methodology: https://510kreport.com/methodology