# K081849: Blackstone Pillar SA Partial Vertebral Body Replacement Device

- Pathway: 510(k) (Special)
- Applicant: Blackstone Medical, Inc.
- Decided: Aug 28, 2008 after 59 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K841189 (1984). 54 ancestors in all.
753 later devices descend from it; 7 cite it directly.
1 of 808 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060350: Construx PL/TL Peek Partial VBR System, Blackstone Medical, Inc. (2006) Summary page 1.
- K051246: Construx Mini Peek VBR System, Blackstone Medical, Inc. (2005) Summary page 1.
- K081177: Blackstone Medical, Inc., Pillar Spacer System, Blackstone Medical, Inc. (2008). Cleared while this submission was under review Summary page 1.
- K051027: Stalif TT, Surgicraft, Ltd. (2005) Summary page 1.
- K041617: Stalif TT, Surgicraft, Ltd. (2004) Summary page 1.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 1.
- K080083: Intrepid Spinal System, Medtronic Sofamor Danek (2008) Summary page 1.

## Most influential descendants
- K100043: Coroent XLR Standalone System (2010), 744 descendants of its own
- K123045: Brigade Standalone System (2013), 696 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K091301: Life Spine Stand-Alone Spacer System (2009), 473 descendants of its own

## Recalls of this device
- Nov 19, 2009 · Not classified · Z-0641-2010: The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning.

## Indications for use
When used as an Intervertebral Body Fusion System: The PILLAR™ SA PEEK Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The PILLAR™ SA PEEK Spacer System is intended for use with autograft. The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR™ Spacer System. When used as a Partial Vertebral Body Replacement (VBR) System: The PILLAR™ SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR™ SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The PILLAR™ SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time. The PILLAR™ SA PEEK Spacer System is intended to be used with autograft or allograft. The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).

Source page: https://510kreport.com/device/K081849
Methodology: https://510kreport.com/methodology