510(k) · Cleared
ClearedBlackstone Pillar XL Peek Spacers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackstone Medical, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 4, 2008 as substantially equivalent to K071795 (Nuvasive, Inc., 2007) after a 28-day review. Its family tree reaches back 2 generations to 2007. 693 later devices descend from it.
- Decided
- Sep 4, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K071922 (2007). 693 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK071922 Interplate Interbody Fusion Device, Models C, CGC, L and LGCRsb Spine, LLC · 2007
- 1 generation backK071795 Nuvasive Coroent SystemNuvasive, Inc. · 2007
- This deviceK082235 Blackstone Pillar XL Peek SpacersBlackstone Medical, Inc. · 2008
- Descendant · cites it directly · 683 of its ownK090166 Avs Anterior Large Peek SpacersStryker Corp. · 2009
- Descendant · 2 generations on · 637 of its ownK093864 Avs Align Peek Spacers Model 48328XXX, 48326XXXStryker Corp. · 2010
- Descendant · 3 generations on · 636 of its ownK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- Descendant · 2 generations on · 470 of its ownK111792 Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model…Signus Medizintechnik GmbH · 2012
- Descendant · 4 generations on · 469 of its ownK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
Showing 5 of 693 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 693 · See all- K090166Avs Anterior Large Peek SpacersStryker Corp. · 2009 · cites it directly683descendants
- K093864Avs Align Peek Spacers Model 48328XXX, 48326XXXStryker Corp. · 2010 · 2 generations on637descendants
- K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation · 2015 · 3 generations on636descendants
- K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH · 2012 · 2 generations on470descendants
- K143616AccuLIF TL and PL CageStryker Corporation · 2015 · 4 generations on469descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071922 | Interplate Interbody Fusion Device, Models C, CGC, L and LGC | Rsb Spine, LLC | 2007 | — |
| −1 | K071795 | Nuvasive Coroent System | Nuvasive, Inc. | 2007 | — |
| 0 (this device) | K082235 | Blackstone Pillar XL Peek Spacers | Blackstone Medical, Inc. | 2008 | — |
| +1 | K090166 | Avs Anterior Large Peek Spacers | Stryker Corp. | 2009 | — |
| +2 | K093864 | Avs Align Peek Spacers Model 48328XXX, 48326XXX | Stryker Corp. | 2010 | — |
| +3 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| +2 | K111792 | Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and… | Signus Medizintechnik GmbH | 2012 | — |
| +4 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 8 | 0 |
| 2016 | 22 | 0 |
| 2017 | 46 | 0 |
| 2018 | 52 | 0 |
| 2019 | 58 | 0 |
| 2020 | 70 | 0 |
| 2021 | 60 | 0 |
| 2022 | 69 | 0 |
| 2023 | 84 | 0 |
| 2024 | 88 | 0 |
| 2025 | 68 | 0 |
| 2026 | 58 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MAX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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…es, which have been cleared by FDA for the purpose of building a spinal implant construct in the non-cervical spine: * Blackstone Medical, Inc. PILLAR Spacer System (K080628 SE 7-23-08) , NuVasive CoRoent System (K071795 SE 12-4-07) PILLAR Spacer System Modification - 510(k) Summary- PILAR XL PE… | |
| * | K071795 | Nuvasive Coroent SystemSummary page 1…August 6, 2008 Substantially Equivalent Devices: * Blackstone Medical, Inc. PILLAR Spacer System (K08 1177 SE 7-23-08) • NuVasive CoRoent System (K07 1795 SE 12-4-07) PILLAR Spacer System Modification - 51 0(k) Summary- PILAR XL PEEKSpacer Page 1 of 3 === Page 2 ==… | 2007 |
What descends from it? (693)
See all 6934 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 3 companies; a new generation was cleared every 9 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K090166 (Stryker Corp., 2009) has gone furthest, with 683 descendants of its own.
- 41 other devices also cite its predicate K071795.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
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…
Read the full statement (362 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082235 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082235: Blackstone Pillar XL Peek Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082235
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026