# K120891: Tangors Multifunctional Posterior System

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich GmbH & Co. KG
- Decided: Oct 1, 2012 after 192 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
Longest line of descent: 6 generations back to K901587 (1990). 38 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102853: Flamenco Spinal Fixation System, Ulrich GmbH & Co. KG (2011) Summary page 2.
- K031655: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2003) Summary page 2.
- K041460: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2004) Summary page 2.
- K041119: Expedium Spine System, Depuy Spine, Inc. (2004). Our reading of the summary gave K041191, FDA’s number for Colleague Volumetric Infusion Pumps (Baxter Healthcare Corp). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Expedium”. Summary page 2.
- K062196: SFX Snap-Fit Cross Connector, Depuy Spine, Inc. (2006) Summary page 2.
- K052385: Tangors Polyaxial System, Ulrich GmbH & Co. KG (2005) Summary page 2.

## Most influential descendants
- K123717: Ucentum (2013), 17 descendants of its own
- K151727: Everest Spinal System (2015), 11 descendants of its own
- K161369: EVEREST Spinal System (2016), 9 descendants of its own
- K181188: EVEREST Spinal System (2018), 6 descendants of its own
- K181603: EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System (2018), 5 descendants of its own

## Indications for use
The tangoRS is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the tangoRS 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, spinal tumor, pseudarthrosis and failed previous fusion.

Source page: https://510kreport.com/device/K120891
Methodology: https://510kreport.com/methodology