510(k) · Cleared
ClearedBlackstone Unity Anterior Lumbar Plate Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackstone Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jun 14, 2005 as substantially equivalent to K013665 (Medtronic Sofamor Danek, Inc., 2002) after a 173-day review. Its family tree reaches back 2 generations to 1993. 211 later devices descend from it.
- Decided
- Jun 14, 2005
- Review
- 173 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922543 (1993). 4 ancestors in all. 211 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- 1 generation backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- This deviceK043548 Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2005
- Descendant · cites it directly · 165 of its ownK061229 Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2006
- Descendant · 2 generations on · 161 of its ownK070922 Modification to Spinal Usa VBR SystemSpinal USA · 2007
- Descendant · 3 generations on · 159 of its ownK091044 Spinal Usa Anterior Lumbar Plate SystemSpinal USA · 2009
- Descendant · 4 generations on · 113 of its ownK121791 Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012
- Descendant · cites it directly · 113 of its ownK101255 Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2010
Showing 5 of 211 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 211 · See all- K061229Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2006 · cites it directly165descendants
- K070922Modification to Spinal Usa VBR SystemSpinal USA · 2007 · 2 generations on161descendants
- K091044Spinal Usa Anterior Lumbar Plate SystemSpinal USA · 2009 · 3 generations on159descendants
- K121791Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012 · 4 generations on113descendants
- K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2010 · cites it directly113descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −1 | K013665 | Pyramid Anterior Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| 0 (this device) | K043548 | Blackstone Unity Anterior Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2005 | — |
| +1 | K061229 | Unity LX Anterolateral Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2006 | — |
| +2 | K070922 | Modification to Spinal Usa VBR System | Spinal USA | 2007 | — |
| +3 | K091044 | Spinal Usa Anterior Lumbar Plate System | Spinal USA | 2009 | — |
| +4 | K121791 | Zou Anterior Lumbar Plate System | Corelink, LLC | 2012 | — |
| +1 | K101255 | Alphatec Spine Anterior Lumbar Plating System | Alphatec Spine, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 7 | 0 |
| 2019 | 11 | 0 |
| 2020 | 17 | 0 |
| 2021 | 15 | 0 |
| 2022 | 24 | 0 |
| 2023 | 34 | 0 |
| 2024 | 28 | 0 |
| 2025 | 27 | 0 |
| 2026 | 34 | 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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K013665 | Pyramid Anterior Plate Fixation SystemSummary page 1…Spinal Intervertebral Body Substantially Equivalent Devices: Medtronic Sofamor Danek PyramidTM Anterior Plate Fixation System (K013665) Device Description: The Blackstone UnityTM Anterior Lumbar Plate Fixation System is comprised of non-sterile, single use, tit… | 2002 |
What descends from it? (211)
See all 2115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061229 | Unity LX Anterolateral Lumbar Plate Fixation System | 2006 | 165 |
| K101255 | Alphatec Spine Anterior Lumbar Plating System | 2010 | 113 |
| K091253 | Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate… | 2009 | 73 |
| K132589 | Anterior Lumbar Plate System (Presidio) | 2013 | 12 |
| K092765 | Lanx Anterior Plating System | 2010 | 1 |
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 12 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K061229 (Blackstone Medical, Inc., 2006) has gone furthest, with 165 descendants of its own.
- 11 other devices also cite its predicate K013665.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The Blackstone Unity TM Anterior Lumbar Plate Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the vascular structures. When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: a) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc…
Read the full statement (133 words)
The Blackstone Unity TM Anterior Lumbar Plate Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the vascular structures.
When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
a) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
b) Pseudoarthrosis
c) Spondylolysis
d) Spondylolisthesis
e) Fracture
f) Neoplastic disease
g) Unsuccessful previous fusion surgery
h) Lordotic deformities of the spine
i) Idiopathic thoracolumbar or lumbar scoliosis
j) Deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele
k) Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043548 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043548: Blackstone Unity Anterior Lumbar Plate Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043548
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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