# K052385: Tangors Polyaxial System

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich GmbH & Co. KG
- Decided: Dec 27, 2005 after 119 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
253 later devices descend from it; 3 cite it directly.
0 of 254 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070387: Expedium Spine System (2007), 248 descendants of its own
- K102249: Expedium Spine System (2010), 218 descendants of its own
- K111571: Viper Systems (2011), 203 descendants of its own
- K121020: Viper System (2012), 94 descendants of its own
- K153442: CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems (2016), 84 descendants of its own

## Indications for use
The tangoRS Polyaxial System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine. When used as a posterior spine thoracic/lumbar system, the tangoRS Polyaxial System is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis), fracture, and spinal tumor.

Source page: https://510kreport.com/device/K052385
Methodology: https://510kreport.com/methodology