# K131810: Osseus Black Diamond Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osseus Fusion Systems, LLC
- Decided: Aug 8, 2013 after 50 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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: 13 generations back to K853033 (1985). 140 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061520: Viper Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K090648: Viper 2 System, Depuy Spine, Inc. (2009) Summary page 1.
- K102701: Viper Spine System, Depuy Spine, Inc. (2010) Summary page 1.
- K111571: Viper Systems, Johnson & Johnson (2011)
- K033352: Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2004) Summary page 1.
- K043152: Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2005) Summary page 1.
- K051716: Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2005) Summary page 1.
- K071376: Modification to Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2007) Summary page 1.
- K081597: Modification to Vertebron PSS Pedicle Screw System, Vertebron, Inc. (2008)
- K940631: Cross Medical - Synergy (TM) Spine System, Cross Medical Products, Inc. (1995) Summary page 1.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 1.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K920116: PWB Lumbosacral Spine System, Cross Medical Products, Inc. (1992) Summary page 1.

## Most influential descendants
- K192121: Black Diamond Pedicle Screw System (2019), 13 descendants of its own
- K213935: PISCES-SA Standalone ALIF Interbody System (2022), 12 descendants of its own
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own
- K240326: Solar™ Lumbar Interbody Fusion System (2024), 4 descendants of its own
- K223413: Pisces™-SA STANDALONE ALIF Interbody System (2023), 3 descendants of its own

## Indications for use
The Osseus Black Diamond 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor. pseudarthrosis and failed previous fusion. The Osseus Black Diamond Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: 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 lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K131810
Methodology: https://510kreport.com/methodology