# K100377: Diamondback Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Eminent Spine
- Decided: Apr 22, 2010 after 69 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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: 4 generations back to K901587 (1990). 25 ancestors in all.
29 later devices descend from it; 4 cite it directly.
0 of 55 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 1.
- K041460: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2004) Summary page 1.
- K992168: Moss Miami 6.35MM Polyaxial Screw, Depuyacromed (1999) Summary page 1.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 1.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 1.
- 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 1.

## Most influential descendants
- K102853: Flamenco Spinal Fixation System (2011), 22 descendants of its own
- 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

## Indications for use
The Diamondback' TM Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion in skeletally mature patients. The system is intended for posterior, pedicle fixation for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-Sl vertebra. In addition, when used as a pedicle screw fixation system of the non-cervical posterior spine (Ti to S2) 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, lordlosis, spinal tumor, pseudlarthrosis and failed previous fusion.

Source page: https://510kreport.com/device/K100377
Methodology: https://510kreport.com/methodology