510(k) · Cleared
ClearedAnterior Lumbar Plate System (Presidio)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Oct 8, 2013 as substantially equivalent to K093200 (Life Spine, 2010) and 1 other predicate after a 50-day review. Its family tree reaches back 3 generations to 1993. 12 later devices descend from it.
- Decided
- Oct 8, 2013
- Review
- 50 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K922543 (1993). 6 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- 2 generations backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 1 generation backK043548 Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2005
- This deviceK132589 Anterior Lumbar Plate System (Presidio)Life Spine, Inc. · 2013
- Descendant · cites it directly · 10 of its ownK172131 2 Hole Lateral Plating SystemLife Spine, Inc. · 2017
- Descendant · cites it directly · 9 of its ownK180166 Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK200338 ProLift Lateral FixatedLife Spine, Inc. · 2020
- Descendant · 3 generations on · 3 of its ownK210061 ProLift Lateral HELO FixatedLife Spine, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK221806 TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K1721312 Hole Lateral Plating SystemLife Spine, Inc. · 2017 · cites it directly10descendants
- K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc. · 2018 · cites it directly9descendants
- K200338ProLift Lateral FixatedLife Spine, Inc. · 2020 · 2 generations on5descendants
- K210061ProLift Lateral HELO FixatedLife Spine, Inc. · 2021 · 3 generations on3descendants
- K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −2 | K013665 | Pyramid Anterior Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −1 | K043548 | Blackstone Unity Anterior Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2005 | — |
| 0 (this device) | K132589 | Anterior Lumbar Plate System (Presidio) | Life Spine, Inc. | 2013 | — |
| +1 | K172131 | 2 Hole Lateral Plating System | Life Spine, Inc. | 2017 | — |
| +1 | K180166 | Life Spine Lumbar Fixation System (SENTRY) | Life Spine, Inc. | 2018 | — |
| +2 | K200338 | ProLift Lateral Fixated | Life Spine, Inc. | 2020 | — |
| +3 | K210061 | ProLift Lateral HELO Fixated | Life Spine, Inc. | 2021 | — |
| +2 | K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | Life Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093200 | Life Spine Lumbar Plate SystemSummary page 1…: Spinal Fixation System Classification: KWQ, CFR 888.3060..Class 11 Predicate Device: Life Spine Anterior Lumbar Fixation System (K093200) Blackstone Unity Anterior Lumbar Fixation System (K043548) Device Description: The Presidio Ant… | 2010 |
| * | K043548 | Blackstone Unity Anterior Lumbar Plate Fixation SystemSummary page 1….Class 11 Predicate Device: Life Spine Anterior Lumbar Fixation System (K093200) Blackstone Unity Anterior Lumbar Fixation System (K043548) Device Description: The Presidio Anterior Lumbar Fixation System consists of a variety of plates and screws to suit the ind… | 2005 |
What descends from it? (12)
See all 123 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 20 years and passes through 4 companies; a new generation was cleared every 8.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K172131 (Life Spine, Inc., 2017) has gone furthest, with 10 descendants of its own.
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. 2013, this device’s year, is highlighted.
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 Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (LI-SI) spine instability as a result of fracture (including dislocation and…
Read the full statement (108 words)
The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (LI-SI) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis. scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132589 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132589: Anterior Lumbar Plate System (Presidio).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132589
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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