510(k) · Cleared
Recalled · 2009Blackstone Pillar SA Partial Vertebral Body Replacement Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackstone Medical, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Aug 28, 2008 as substantially equivalent to K060350 (Blackstone Medical, Inc., 2006) and 6 other predicates after a 59-day review. Its family tree reaches back 11 generations to 1984. 1 of the 808 devices in its family, counting itself, has a Class I recall. 753 later devices descend from it. It has been recalled once.
- Decided
- Aug 28, 2008
- Review
- 59 days
- Class
- Class II
- Product code
- OVD
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 11 generations to K841189 (1984). 54 ancestors in all. 753 later devices descend from it, 7 citing it directly. 1 of the 808 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 1 generation backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- This deviceK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008
- Descendant · cites it directly · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- Descendant · 2 generations on · 696 of its ownK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- Descendant · 3 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 4 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · cites it directly · 473 of its ownK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 1 generation backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- This deviceK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008
Showing 5 of 753 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 753 · See all- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · cites it directly744descendants
- K123045Brigade Standalone SystemNuvasive, Inc. · 2013 · 2 generations on696descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 3 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 4 generations on479descendants
- K091301Life Spine Stand-Alone Spacer SystemLife Spine · 2009 · cites it directly473descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −1 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| 0 (this device) | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | — |
| +1 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| +2 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| +3 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +4 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +1 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 9 | 0 |
| 2015 | 16 | 0 |
| 2016 | 37 | 0 |
| 2017 | 43 | 0 |
| 2018 | 52 | 0 |
| 2019 | 63 | 0 |
| 2020 | 82 | 0 |
| 2021 | 67 | 1 |
| 2022 | 68 | 0 |
| 2023 | 79 | 0 |
| 2024 | 88 | 0 |
| 2025 | 76 | 0 |
| 2026 | 63 | 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K060350 | Construx PL/TL Peek Partial VBR SystemSummary page 1…l Body Fixation Orthosis Substantially Equivalent Devices: PILLAR SA4 PEEK Spacer System - 510(k) Summary Blackstone Medical, Inc. Construx PL/TL Partial VBR Spacers (K060350 SE 2-24-06) Blackstone Medical, Inc. Construx Mini (K051246 SE 6-14-05) Blackstone Medical, Inc. PILLAR Spacer System (K081177 S… | 2006 |
| * | K051246 | Construx Mini Peek VBR SystemSummary page 1…PILLAR SA4 PEEK Spacer System - 510(k) Summary Blackstone Medical, Inc. Construx PL/TL Partial VBR Spacers (K060350 SE 2-24-06) Blackstone Medical, Inc. Construx Mini (K051246 SE 6-14-05) Blackstone Medical, Inc. PILLAR Spacer System (K081177 SE 7-23-08) Surgicraft, Ltd. STALIF TT (K041617 SE 9-8-04 an… | 2005 |
| * | K081177 | Blackstone Medical, Inc., Pillar Spacer System Cleared while this submission was under review Summary page 1…Inc. Construx PL/TL Partial VBR Spacers (K060350 SE 2-24-06) Blackstone Medical, Inc. Construx Mini (K051246 SE 6-14-05) Blackstone Medical, Inc. PILLAR Spacer System (K081177 SE 7-23-08) Surgicraft, Ltd. STALIF TT (K041617 SE 9-8-04 and K051027 SE 6-29-05) Surgicraft, Ltd., STALIF TT Intervertebral Bod… | 2008 |
| * | K051027 | Stalif TTSummary page 1…e Medical, Inc. Construx Mini (K051246 SE 6-14-05) Blackstone Medical, Inc. PILLAR Spacer System (K081177 SE 7-23-08) Surgicraft, Ltd. STALIF TT (K041617 SE 9-8-04 and K051027 SE 6-29-05) Surgicraft, Ltd., STALIF TT Intervertebral Body Fusion System (K073109 SE 6-4-08) Medtronic Sofamor Danek, Intrepid S… | 2005 |
| * | K041617 | Stalif TTSummary page 1…SE 2-24-06) Blackstone Medical, Inc. Construx Mini (K051246 SE 6-14-05) Blackstone Medical, Inc. PILLAR Spacer System (K081177 SE 7-23-08) Surgicraft, Ltd. STALIF TT (K041617 SE 9-8-04 and K051027 SE 6-29-05) Surgicraft, Ltd., STALIF TT Intervertebral Body Fusion System (K073109 SE 6-4-08) Medtronic Sof… | 2004 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 1…Spacer System (K081177 SE 7-23-08) Surgicraft, Ltd. STALIF TT (K041617 SE 9-8-04 and K051027 SE 6-29-05) Surgicraft, Ltd., STALIF TT Intervertebral Body Fusion System (K073109 SE 6-4-08) Medtronic Sofamor Danek, Intrepid Spinal System (K080083 SE 4-10-08) Page 1 of 3 Premarket Notificati… | 2008 |
| * | K080083 | Intrepid Spinal SystemSummary page 1…1617 SE 9-8-04 and K051027 SE 6-29-05) Surgicraft, Ltd., STALIF TT Intervertebral Body Fusion System (K073109 SE 6-4-08) Medtronic Sofamor Danek, Intrepid Spinal System (K080083 SE 4-10-08) Page 1 of 3 Premarket Notification Special 510(k) kD%W‘lfi Blackstone Medical, Inc. ’ PILLAR SA PEEK… | 2008 |
What descends from it? (753)
See all 7537 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100043 | Coroent XLR Standalone System | 2010 | 744 |
| K091301 | Life Spine Stand-Alone Spacer System | 2009 | 473 |
| K161129 | Pillar SA PTC | 2016 | 19 |
| K162446 | FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK… | 2016 | 6 |
| K231199 | Solar Lumbar Interbody Fusion System | 2023 | 5 |
| K132596 | Proposed Optimus | 2014 | 5 |
| K241468 | Vertiwedge® Intraosseous System | 2024 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2009 | Not classified | Z-0641-2010 | Nonconforming Material/Component | The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning. |
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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 10 companies; a new generation was cleared every 9 months on median.
- 7 of the 54 ancestors have a recall of any class.
- Of its descendants, K100043 (Nuvasive, Inc., 2010) has gone furthest, with 744 descendants of its own.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
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…
Read the full statement (383 words)
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).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K081849 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081849: Blackstone Pillar SA Partial Vertebral Body Replacement Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081849
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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