# K081684: Blackstone Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Sep 15, 2008 after 90 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K980447 (1998). 20 ancestors in all.
277 later devices descend from it; 7 cite it directly.
0 of 298 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994217: Blackstone Spinal Fixation System, Blackstone Medical, Inc. (2000) Summary page 2.
- K020674: Blackstone Spinal Fixation System 4.5MM Multi-Axial Screw, Blackstone Medical, Inc. (2002) Summary page 2.
- K013558: Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw, Blackstone Medical, Inc. (2002) Summary page 2.
- K003735: Blackstone Spinal Fixation System, Second-Generation Cross-Connector, Blackstone Medical, Inc. (2001) Summary page 2.
- K023498: Modification to Blackstone Spinal Fixation System, Blackstone Medical, Inc. (2002) Summary page 2.
- K030581: Blackstone Spinal Fixation System Lateral Offset (System Modification), Blackstone Medical, Inc. (2003) Summary page 2.
- K030862: Blackstone Spinal Fixation System Rigid Cross Connector, Blackstone Medical, Inc. (2003) Summary page 2.
- K080407: Blackstone SFS Parallel Rod Connectors, 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
- K082797: Blackstone Pedicle Screw System (2008), 209 descendants of its own
- 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

## Recalls of this device
- Nov 26, 2013 · Class II · Z-0855-2014: Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the s
- Oct 22, 2010 · Not classified · Z-1674-2011: There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance.
- Oct 22, 2010 · Not classified · Z-1608-2011: There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies.

## 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/K081684
Methodology: https://510kreport.com/methodology