510(k) · Cleared
ClearedChoice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choicespine, LP · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 19, 2016 as substantially equivalent to K143740 (Alphatec Spine, Inc., 2015) and 5 other predicates after a 205-day review. Its family tree reaches back 14 generations to 1984. 171 later devices descend from it.
- Decided
- May 19, 2016
- Review
- 205 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K841189 (1984). 89 ancestors in all. 171 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK103169 AleuttianK2m, Inc. · 2011
- 2 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 1 generation backK140142 Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP · 2014
- This deviceK153107 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- Descendant · cites it directly · 161 of its ownK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- Descendant · cites it directly · 116 of its ownK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
- Descendant · 2 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 81 of its ownK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 6 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 5 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 4 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 3 generations backK103169 AleuttianK2m, Inc. · 2011
- 2 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 1 generation backK140142 Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP · 2014
- This deviceK153107 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
Showing 5 of 171 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 171 · See all- K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP · 2016 · cites it directly161descendants
- K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017 · cites it directly116descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 2 generations on104descendants
- K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 3 generations on102descendants
- K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc. · 2020 · 4 generations on81descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −6 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −5 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −4 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −3 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −2 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −1 | K140142 | Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon) | Choicespine, LP | 2014 | — |
| 0 (this device) | K153107 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| +1 | K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| +1 | K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System | Choicespine | 2017 | — |
| +2 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| +3 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| +4 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 10 | 0 |
| 2008 | 9 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 9 | 0 |
| 2020 | 9 | 0 |
| 2021 | 13 | 0 |
| 2022 | 20 | 0 |
| 2023 | 18 | 0 |
| 2024 | 31 | 0 |
| 2025 | 32 | 0 |
| 2026 | 28 | 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? (6)
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 |
|---|---|---|---|
| * | K143740 | Battalion Universal Spacer SystemSummary page 7…parison of The implants included in this submission are equivalent to the primary predicate Technological Alphatec Battalion Universal Spacer System (K143740), and additional predicates Characteristics: are Choice Spine Lumbar Spacer System (K140142 and K073669), Choice Spine… | 2015 |
| * | K140142 | Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Summary page 5…nce for additional devices Submission: manufactured from titanium-alloy. The previously cleared system are Choice Spine Lumbar Spacer System, K140142 and K073669, Choice Spine VEO™ Lateral Access & Interbody Fusion System (Formerly TranS1 Lateral Interbody… | 2014 |
| * | K073669 | Oria Natura SpacerSummary page 5…tional devices Submission: manufactured from titanium-alloy. The previously cleared system are Choice Spine Lumbar Spacer System, K140142 and K073669, Choice Spine VEO™ Lateral Access & Interbody Fusion System (Formerly TranS1 Lateral Interbody… | 2008 |
| * | K120991 | TRANS1 Interbody Fusion SystemSummary page 5…Interbody Fusion System) K100210 and K123997, and Choice Spine Interbody Fusion System (Formerly TranS1 Interbody Fusion System) K120991. The latter two TranS1 systems were acquired by Choice Spine in 2015.… | 2012 |
| * | K100210 | TRANS1 Lateral Intervertebral Fusion Device, TSummary page 5…K140142 and K073669, Choice Spine VEO™ Lateral Access & Interbody Fusion System (Formerly TranS1 Lateral Interbody Fusion System) K100210 and K123997, and Choice Spine Interbody Fusion System (Formerly TranS1 Interbody Fusion System) K120991. The… | 2010 |
| * | K123997 | TRANS1LATERAL Interbody Fusion SystemSummary page 5…K073669, Choice Spine VEO™ Lateral Access & Interbody Fusion System (Formerly TranS1 Lateral Interbody Fusion System) K100210 and K123997, and Choice Spine Interbody Fusion System (Formerly TranS1 Interbody Fusion System) K120991. The latter two… | 2013 |
What descends from it? (171)
See all 1713 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 32 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 13 of the 89 ancestors have a recall of any class.
- Of its descendants, K162103 (Choicespine, LP, 2016) has gone furthest, with 161 descendants of its own.
- 5 other devices also cite its predicate K143740.
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. 2016, 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?
Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon): The Choice Spine Lumbar Spacer System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1 in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back…
Read the full statement (395 words)
Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon):
The Choice Spine Lumbar Spacer System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1 in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
When used as a vertebral body replacement device, the Choice Spine Intervertebral Body Device is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Choice Spine VEO™ Lateral Access & Interbody Fusion System:
The Choice Spine VEO™ Lateral Access & Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Choice Spine VEO™ Lateral Access & Interbody Fusion System is designed to be used with autogenous graft and supplemental spinal fixation that is cleared for use in the lumbar spine.
Choice Spine Interbody Fusion System:
The Choice Spine Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Choice Spine Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.
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/K153107 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153107: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153107
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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