510(k) · Cleared
ClearedChoice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)
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 Jul 16, 2014 as substantially equivalent to K051454 (K2m, LLC, 2005) and 3 other predicates after a 175-day review. Its family tree reaches back 13 generations to 1984. 172 later devices descend from it.
- Decided
- Jul 16, 2014
- Review
- 175 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K841189 (1984). 60 ancestors in all. 172 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 2 generations backK103169 AleuttianK2m, Inc. · 2011
- 1 generation backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- This deviceK140142 Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP · 2014
- Descendant · cites it directly · 171 of its ownK153107 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 · 2 generations on · 116 of its ownK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
- Descendant · 3 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 5 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 4 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 3 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 2 generations backK103169 AleuttianK2m, Inc. · 2011
- 1 generation backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- This deviceK140142 Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP · 2014
Showing 5 of 172 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 172 · 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 · cites it directly161descendants
- K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017 · 2 generations on116descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 3 generations on104descendants
- K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 4 generations on102descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −5 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −4 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −3 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −2 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −1 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| 0 (this device) | K140142 | Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon) | Choicespine, LP | 2014 | — |
| +1 | 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 | — |
| +2 | K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System | Choicespine | 2017 | — |
| +3 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| +4 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K051454 | Aleutian Spacer SystemSummary page 2…te devices. The 9mm width trials are manufactured from 17-4 Stainless Steel per ASTM F899 and are biocompatible. Predicate Device(s): K2M, LLC Aleutian Spacer System K(051454, K130699 Innovasis, Inc., Box Peek VBR System K062151 Choice Spine Lumbar Spacer System, K(073669 Performance Standards: Perform… | 2005 |
| * | K130699 | Aleutian Spinal SystemSummary page 2…es. The 9mm width trials are manufactured from 17-4 Stainless Steel per ASTM F899 and are biocompatible. Predicate Device(s): K2M, LLC Aleutian Spacer System K(051454, K130699 Innovasis, Inc., Box Peek VBR System K062151 Choice Spine Lumbar Spacer System, K(073669 Performance Standards: Performance test… | 2013 |
| * | K062151 | Box Peek VBR SystemSummary page 2…om 17-4 Stainless Steel per ASTM F899 and are biocompatible. Predicate Device(s): K2M, LLC Aleutian Spacer System K(051454, K130699 Innovasis, Inc., Box Peek VBR System K062151 Choice Spine Lumbar Spacer System, K(073669 Performance Standards: Performance testing was completed by an independent laborator… | 2006 |
| * | K073669 | Oria Natura SpacerSummary page 2…biocompatible. Predicate Device(s): K2M, LLC Aleutian Spacer System K(051454, K130699 Innovasis, Inc., Box Peek VBR System K062151 Choice Spine Lumbar Spacer System, K(073669 Performance Standards: Performance testing was completed by an independent laboratory following ASTM F2077-1 1 and ASTM F2267-04… | 2008 |
What descends from it? (172)
See all 1722 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 30 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 60 ancestors have a recall of any class.
- Of its descendants, K153107 (Choicespine, LP, 2016) has gone furthest, with 171 descendants of its own.
- 7 other devices also cite its predicate K051454.
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. 2014, 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?
When used as an intervertebral body fusion device, Choice Spine Lumbar Spacers are 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…
Read the full statement (177 words)
When used as an intervertebral body fusion device, Choice Spine Lumbar Spacers are 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 (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.
When used as a vertebral body replacement device, Choice Spine Lumbar Spacers are 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 (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140142: Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140142
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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