# K082797: Blackstone Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Blackstone Medical, Inc.
- Decided: Oct 17, 2008 after 24 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: 6 generations back to K980447 (1998). 21 ancestors in all.
209 later devices descend from it; 9 cite it directly.
0 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081684: Blackstone Pedicle Screw System, Blackstone Medical, Inc. (2008) Summary page 2.
- K052123: Synthes Pangea System, Synthes (Usa) (2005) Summary page 2.
- K052151: Synthes Pangea Monoaxial System, Synthes Spine Co.Lp (2005) Summary page 2.

## Most influential descendants
- K092624: Firebird Spinal Fixation System (2009), 130 descendants of its own
- K100044: Firebird Spinal Fixation System, Firebird Side-Loading Body (2010), 117 descendants of its own
- K122901: Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System (2012), 116 descendants of its own
- K100623: Aesculap Implant Systems S4 Spinal System (2010), 92 descendants of its own
- K093926: Firebird Spinal Fixation System (2010), 88 descendants of its own

## Indications for use
The Blackstone Pedicle Screw System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications regardless of the intended use: 1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) 2) spondylolisthesis, 3) trauma (i.e., fracture or dislocation), 4) spinal stenosis, 5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6) tumor, 7) pseudoarthrosis, and 8) failed previous fusion The Blackstone Pedicle Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

Source page: https://510kreport.com/device/K082797
Methodology: https://510kreport.com/methodology