# K192121: Black Diamond Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osseus Fusion Systems
- Decided: Oct 29, 2019 after 84 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: 19 generations back to K003155 (2001). 522 ancestors in all.
13 later devices descend from it; 1 cites it directly.
1 of 536 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090984: Inertia Pedicle Screw System, Nexxt Spine, LLC (2009) Summary page 4.
- K101278: Inertia Pedicle Screw System, Nexxt Spine, LLC (2010) Summary page 4.
- K132412: Inertia Mis Pedicle Screw System, Nexxt Spine, LLC (2013) Summary page 4.
- K153453: Inertia Pedicle Screw and Deformity Correxxion System, Nexxt Spine, LLC (2016) Summary page 4.
- K131810: Osseus Black Diamond Pedicle Screw System, Osseus Fusion Systems, LLC (2013) Summary page 4.
- K150896: Vitality Spinal Fixation System, Zimmer Spine, Inc. (2015) Summary page 4.
- K171907: Vitality® Spinal Fixation System, Zimmer Biomet Spine, Inc. (2017). Our reading of the summary gave K171900, FDA’s number for Acclarix AX4 Diagnostic Ultrasound System (Edan Instruments, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Vitality® Spinal Fixation System, Zimmer Spine, Inc.”.
- K091291: Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod, Stryker Spine (2009) Summary page 4.
- K113666: Xia 3 Spinal System, Stryker Spine (2012) Summary page 4.
- K142381: Xia 3 Spinal System, Stryker Corp. (2014) Summary page 4.
- K132925: Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T, Low-Top, Savannah-Link, Amendia, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K241077: DeGen Medical Patient Specific Implant (PSI) System (2024), 2 descendants of its own

## Indications for use
The Black Diamond Pedicle Screw System, with or without MIS instrumentation, 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 disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 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. When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Black Diamond Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Black Diamond Pedicle Screw System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K192121
Methodology: https://510kreport.com/methodology