# K123717: Ucentum

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich GmbH & Co. KG
- Decided: Mar 4, 2013 after 90 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 8 generations back to K990745 (1999). 58 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052385: Tangors Polyaxial System, Ulrich GmbH & Co. KG (2005) Summary page 2.
- K120891: Tangors Multifunctional Posterior System, Ulrich GmbH & Co. KG (2012) Summary page 2.
- K102853: Flamenco Spinal Fixation System, Ulrich GmbH & Co. KG (2011)
- 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.
- K110280: Revlok Fenestrated Screw System, Globus Medical, Inc. (2011) Summary page 2.

## Most influential descendants
- 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
- K222684: XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi (2023), 4 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 uCentumTM comprehensive posterior system 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 uCentum 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 lordlosis), fracture, spinal tumor, pseudarthrosis and failed previous fusion.

Source page: https://510kreport.com/device/K123717
Methodology: https://510kreport.com/methodology