510(k) · Cleared
ClearedBattalion Universal Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 22, 2015 as substantially equivalent to K080699 (Alphatec Spine, Inc., 2008) and 1 other predicate after a 143-day review. Its family tree reaches back 3 generations to 2001. 247 later devices descend from it.
- Decided
- May 22, 2015
- Review
- 143 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P980048 (2001). 8 ancestors in all. 247 later devices descend from it, 6 citing it directly.
- Root · 3 generations backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
- 2 generations backK112036 Calix PC Spinal Implant SystemX-Spine Systems, Inc. · 2011
- 1 generation backK110632 Lucent or Lucent MagnumSpinal Elements, Inc. · 2012 · Recalled
- This deviceK143740 Battalion Universal Spacer SystemAlphatec Spine, Inc. · 2015
- Descendant · cites it directly · 171 of its ownK153107 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- Descendant · 2 generations on · 161 of its ownK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- Descendant · 2 generations on · 116 of its ownK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
- Descendant · cites it directly · 114 of its ownK160958 Battalion Universal Spacer SystemAlphatec Spine · 2016
- Descendant · 2 generations on · 113 of its ownK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
Showing 5 of 247 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 247 · See all- K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP · 2016 · cites it directly171descendants
- K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP · 2016 · 2 generations on161descendants
- K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017 · 2 generations on116descendants
- K160958Battalion Universal Spacer SystemAlphatec Spine · 2016 · cites it directly114descendants
- K180480ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018 · 2 generations on113descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | Sulzer Spine-Tech | 2001 | — |
| −2 | K112036 | Calix PC Spinal Implant System | X-Spine Systems, Inc. | 2011 | — |
| −1 | K110632 | Lucent or Lucent Magnum | Spinal Elements, Inc. | 2012 | 1 |
| 0 (this device) | K143740 | Battalion Universal Spacer System | Alphatec Spine, Inc. | 2015 | — |
| +1 | K153107 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| +2 | K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| +2 | K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System | Choicespine | 2017 | — |
| +1 | K160958 | Battalion Universal Spacer System | Alphatec Spine | 2016 | — |
| +2 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 9 | 0 |
| 2019 | 15 | 0 |
| 2020 | 21 | 0 |
| 2021 | 20 | 0 |
| 2022 | 29 | 0 |
| 2023 | 29 | 0 |
| 2024 | 38 | 0 |
| 2025 | 40 | 0 |
| 2026 | 37 | 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 MAX? 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? (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 |
|---|---|---|---|
| * | K080699 | Novel Spinal Spacer SystemSummary page 5…device (21 CFR 888.3080) Regulatory Class: II Product Code: MAX III. PREDICATE DEVICE(S) Novel® Spinal Spacer System, K080699 (primary predicate) Lucent® and Lucent Magnum®, K110632 (additional predicate) IV. DEVICE DESCRIPTION The Batta… | 2008 |
| * | K110632 | Lucent or Lucent MagnumSummary page 5…I Product Code: MAX III. PREDICATE DEVICE(S) Novel® Spinal Spacer System, K080699 (primary predicate) Lucent® and Lucent Magnum®, K110632 (additional predicate) IV. DEVICE DESCRIPTION The Battalion Universal Spacer System is an intervertebral body fusion s… | 2012 |
What descends from it? (247)
See all 2476 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153107 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™… | 2016 | 171 |
| K160958 | Battalion Universal Spacer System | 2016 | 114 |
| K181453 | ATEC ALIF Spacer System | 2018 | 111 |
| K182746 | ATEC ALIF and LLIF Spacer System | 2018 | 110 |
| K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | 2018 | 55 |
| K201367 | FlareHawk TiHawk9 Interbody Fusion System | 2020 | 2 |
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 14 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K153107 (Choicespine, LP, 2016) has gone furthest, with 171 descendants of its own.
- 10 other devices also cite its predicate K080699.
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. 2015, 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?
The Battalion 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 discogenic spinal pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have had at least six months of non-operative treatment. Lumbar DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Battalion System is to be used with autogenous bone graft and supplemental fixation.
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/K143740 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143740: Battalion Universal Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143740
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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