# K082235: Blackstone Pillar XL Peek Spacers

- Pathway: 510(k) (Special)
- Applicant: Blackstone Medical, Inc.
- Decided: Sep 4, 2008 after 28 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K071922 (2007). 2 ancestors in all.
693 later devices descend from it; 4 cite it directly.
0 of 696 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K080628: Blackstone Medical, Inc. PILLAR Spacer System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 3.

## Most influential descendants
- K090166: Avs Anterior Large Peek Spacers (2009), 683 descendants of its own
- K093864: Avs Align Peek Spacers Model 48328XXX, 48326XXX (2010), 637 descendants of its own
- K143163: AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System (2015), 636 descendants of its own
- K111792: Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and Mini (2012), 470 descendants of its own
- K143616: AccuLIF TL and PL Cage (2015), 469 descendants of its own

## Indications for use
When used as an intervertebral body fusion device, the PILLAR™ 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 I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The PILLAR™ Spacer System is intended for use with autograft and supplemental internal fixation. 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. The PILLAR™ PL spacer is used singly or in pairs, and is implanted using a posterior approach. The PILLAR™ TL spacer is used singly or in pairs, and is implanted using a transforaminal approach. The PILLAR™ AL spacer is used singly, and is implanted using an anterior approach. The PILLAR™ XL spacer is used singly, and is implanted using a lateral approach. When used as a Partial Vertebral Body Replacement (VBR System, the PILLAR™ 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™ Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The PILLAR™ 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 Partial VBR device is intended to be used with autograft or allograft. The PILLAR™ Spacer System is intended for use with internal fixation. 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/K082235
Methodology: https://510kreport.com/methodology