510(k) · Cleared
ClearedBlackstone Medical, Inc., Pillar Spacer System
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 Jul 23, 2008 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 2 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1999. 1 of the 852 devices in its family, counting itself, has a Class I recall. 848 later devices descend from it.
- Decided
- Jul 23, 2008
- Review
- 89 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to P960025 (1999). 3 ancestors in all, the oldest P950019 (1996). 848 later devices descend from it, 5 citing it directly. 1 of the 852 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backP960025 Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle…Depuy Spine, Inc. · 1999
- 1 generation backK072791 Oracle Spacer, Opal SpacerSynthes Spine · 2007 · Recalled
- This deviceK081177 Blackstone Medical, Inc., Pillar Spacer SystemBlackstone Medical, Inc. · 2008
- Descendant · cites it directly · 753 of its ownK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- Descendant · 3 generations on · 696 of its ownK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- Descendant · 4 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 5 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Showing 5 of 848 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 848 · See all- K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · cites it directly753descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 2 generations on744descendants
- K123045Brigade Standalone SystemNuvasive, Inc. · 2013 · 3 generations on696descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 4 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 5 generations on479descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws | Depuy Spine, Inc. | 1999 | — |
| −1 | K072791 | Oracle Spacer, Opal Spacer | Synthes Spine | 2007 | 1 |
| 0 (this device) | K081177 | Blackstone Medical, Inc., Pillar Spacer System | Blackstone Medical, Inc. | 2008 | — |
| +1 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| +2 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| +3 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| +4 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +5 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 17 | 0 |
| 2015 | 20 | 0 |
| 2016 | 43 | 0 |
| 2017 | 55 | 0 |
| 2018 | 59 | 0 |
| 2019 | 69 | 0 |
| 2020 | 88 | 0 |
| 2021 | 73 | 1 |
| 2022 | 75 | 0 |
| 2023 | 91 | 0 |
| 2024 | 94 | 0 |
| 2025 | 79 | 0 |
| 2026 | 67 | 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.
1 device in this family has a Class I recall. 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? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 2…tem Confidential Predicate Devices: DePuy Acromed SaberTM Lumbar I/F Cage®, (P960025) Surgical Dynamics, Inc. Ray Threaded Fusion Cage (TFC) (P950019)… | 1999 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 2…DePuy Acromed SaberTM Lumbar I/F Cage®, (P960025) Surgical Dynamics, Inc. Ray Threaded Fusion Cage (TFC) (P950019) Synthes Spine Opal Spacer System (K072791 SE 12-26-07) Intended Use / Indications for Use When u… | 1996 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 2…Surgical Dynamics, Inc. Ray Threaded Fusion Cage (TFC) (P950019) Synthes Spine Opal Spacer System (K072791 SE 12-26-07) Intended Use / Indications for Use When used as an intervertebral body fusion device, the PILLARTM Spacer System i… | 2007 |
What descends from it? (848)
See all 8485 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K081849 (Blackstone Medical, Inc., 2008) has gone furthest, with 753 descendants of its own.
- 98 other devices also cite its predicate P960025.
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 1 spondylolisthesis at the involved…
Read the full statement (345 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 1 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, e.g.: the Blackstone Medical ICON Modular Pedicle Screw System, or the Blackstone Medical Inc. SFS Spinal Fixation System.
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.
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. The supplemental internal fixation system that may be used with the PILLAR Spacer System is the Blackstone Medical Spinal Fixation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081177 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081177: Blackstone Medical, Inc., Pillar Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081177
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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