# K151704: Diplomat® Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medizintechnik GmbH
- Decided: Apr 13, 2016 after 294 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: 11 generations back to K901587 (1990). 253 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 258 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000236: Synergy VLS Cap Nut Models 2206, 6102, Interpore Cross Intl. (2000) Summary page 6.
- K131820: Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax Vertebral Balloon System, 11G, Care Fusion (2013) Summary page 6.
- K103490: Expedium Spine System, Moss Miami Spine System, Johnson & Johnson (2011) Summary page 6.
- K033901: Merlin Spine System, Depuy Spine, Inc. (2004) Summary page 6.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 6.
- K081080: TSRH Spinal System, Medtronic Sofamor Danek (2008) Summary page 6.
- K020279: Forex Corporation, Optima, Spinal System, Forex Corp. (2002) Summary page 6.
- K051971: Optima Spinal System, U&I Corp. (2005) Summary page 6.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 6.
- K102870: Exactech Proliant Polyaxial Pedicle Screw System, Exactech, Inc. (2011) Summary page 6.
- K120838: Synthes Matrix System, Synthes Spine (2012) Summary page 6.
- K110280: Revlok Fenestrated Screw System, Globus Medical, Inc. (2011) Summary page 6.
- K123717: Ucentum, Ulrich GmbH & Co. KG (2013) Summary page 6.

## Most influential descendants
- K191932: Momentum™ Posterior Spinal Fixation System (2019), 2 descendants of its own
- K231809: Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement (2023), 1 descendant of its own
- K251719: Momentum® Posterior Spinal Fixation System (2025), 0 descendants of its own
- K243281: LOCK-IN Spinal Fixation System (2024), 0 descendants of its own

## Indications for use
The DIPLOMAT® Spinal System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: - Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - Spondylolisthesis - Spinal stenosis - Fracture - Dislocation - Scoliosis - Kyphosis - Spinal tumor - Pseudoarthrosis - Failed previous fusion In addition, the DIPLOMAT® Spinal System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium. The DIPLOMAT® Spinal System is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K151704
Methodology: https://510kreport.com/methodology