# K102853: Flamenco Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich GmbH & Co. KG
- Decided: Jan 25, 2011 after 118 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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: 5 generations back to K901587 (1990). 33 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K992168: Moss Miami 6.35MM Polyaxial Screw, Depuyacromed (1999) Summary page 2.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 2.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 2.
- K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems, Cross Medical Products, Inc. (1998) Summary page 2.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 2.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 2.
- K051971: Optima Spinal System, U&I Corp. (2005) Summary page 2.
- K100377: Diamondback Spinal System, Eminent Spine (2010) Summary page 2.

## Most influential descendants
- K120891: Tangors Multifunctional Posterior System (2012), 18 descendants of its own
- 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

## Recalls of this device
- Mar 8, 2019 · Class II · Z-1126-2019: Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.

## Indications for use
The flamencoTM is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (Ti to 82), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients. When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., non-pedicle screw), the flamencoTM is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordlosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

Source page: https://510kreport.com/device/K102853
Methodology: https://510kreport.com/methodology