510(k) · Cleared
ClearedAlphatec Spine Anterior Lumbar Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 21, 2010 as substantially equivalent to K091044 (Spinal USA, 2009) and 2 other predicates after a 78-day review. Its family tree reaches back 6 generations to 1993. 113 later devices descend from it.
- Decided
- Jul 21, 2010
- Review
- 78 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K922543 (1993). 12 ancestors in all. 113 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- 5 generations backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 4 generations backK043548 Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2005
- 3 generations backK061229 Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2006
- 2 generations backK070922 Modification to Spinal Usa VBR SystemSpinal USA · 2007
- 1 generation backK091044 Spinal Usa Anterior Lumbar Plate SystemSpinal USA · 2009
- This deviceK101255 Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2010
- Descendant · cites it directly · 110 of its ownK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · 2 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 2 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 113 · See all- K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018 · cites it directly110descendants
- K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 2 generations on99descendants
- K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019 · 2 generations on78descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 3 generations on69descendants
- K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 3 generations on67descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −5 | K013665 | Pyramid Anterior Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −4 | K043548 | Blackstone Unity Anterior Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2005 | — |
| −3 | K061229 | Unity LX Anterolateral Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2006 | — |
| −2 | K070922 | Modification to Spinal Usa VBR System | Spinal USA | 2007 | — |
| −1 | K091044 | Spinal Usa Anterior Lumbar Plate System | Spinal USA | 2009 | — |
| 0 (this device) | K101255 | Alphatec Spine Anterior Lumbar Plating System | Alphatec Spine, Inc. | 2010 | — |
| +1 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +2 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +2 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +3 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| +3 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 10 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 17 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 21 | 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? (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 |
|---|---|---|---|
| * | K091044 | Spinal Usa Anterior Lumbar Plate SystemSummary page 1…System Clearance Spinal USA Anterior Lumbar Plate System K09 1044 Blackstone Medical Unity Anterior Lumbar Plate Fixation System K043548 BlackstonelvMedical Unity… | 2009 |
| * | K043548 | Blackstone Unity Anterior Lumbar Plate Fixation SystemSummary page 1…Anterior Lumbar Plate System K09 1044 Blackstone Medical Unity Anterior Lumbar Plate Fixation System K043548 BlackstonelvMedical Unity LX Anterolateral Lumbar Plate Fixation System K06 1229 Device Description: The Aiphat… | 2005 |
| * | K061229 | Unity LX Anterolateral Lumbar Plate Fixation SystemSummary page 1…Medical Unity Anterior Lumbar Plate Fixation System K043548 BlackstonelvMedical Unity LX Anterolateral Lumbar Plate Fixation System K06 1229 Device Description: The Aiphatec Spine Anterior Lumbar Plating System is a spinal fixation system that consists of a variety of… | 2006 |
What descends from it? (113)
See all 1133 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 17 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K182746 (Alphatec Spine, Inc., 2018) has gone furthest, with 110 descendants of its own.
- 6 other devices also cite its predicate K091044.
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. 2010, 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 Aiphatec Spine Anterior Lumbar Plating System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Alphatec Spine Anterior Lumbar Plating System is intended for anterior…
Read the full statement (150 words)
The Aiphatec Spine Anterior Lumbar Plating System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved.
The Alphatec Spine Anterior Lumbar Plating System is intended for anterior lumbar spine (LI -SI) fixation for the following indications:
1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
2. Pseudloarthrosis
3. Spondylolysis
4. Spondylolisthesis
5. Trauma (i.e., fracture or dislocation)
6. Spinal stenosis
7. Unsuccessful previous fusion surgery
8. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
9. Tumrne
The Aiphatec Spine Anterior Lumbar Plating System is intended to be used with autograft and/or allograft as an adjunct to fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101255: Alphatec Spine Anterior Lumbar Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101255
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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