510(k) · Cleared
ClearedChoice Spine Hawkeye Vertebral Body Replacement (VBR) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choicespine · MQP Spinal Vertebral Body Replacement Device
Cleared on Feb 22, 2019 as substantially equivalent to K171686 (Choicespine, 2017) and 1 other predicate after a 63-day review. Its family tree reaches back 21 generations to 1984. 1 of the 226 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Feb 22, 2019
- Review
- 63 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K841189 (1984). 220 ancestors in all. 5 later devices descend from it, 3 citing it directly. 1 of the 226 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- 2 generations backK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- 1 generation backK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
- This deviceK183588 Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine · 2019
- Descendant · cites it directly · 1 of its ownK202637 F3D Corpectomy SystemCorelink, LLC · 2020
- Descendant · cites it directly · 1 of its ownK192145 Galileo Vertebral Body Replacement DeviceBright Spine · 2020
- Descendant · cites it directly · 0 of its ownK222874 CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK230329 F3D Interbody SystemCorelink, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK221542 Galileo Vertebral Body Replacement DeviceBright Spine · 2023
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 11 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 10 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 9 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 8 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 7 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 6 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 5 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 4 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 3 generations backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- 2 generations backK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- 1 generation backK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
- This deviceK183588 Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine · 2019
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 5 of 5 · See all- K202637F3D Corpectomy SystemCorelink, LLC · 2020 · cites it directly1descendant
- K192145Galileo Vertebral Body Replacement DeviceBright Spine · 2020 · cites it directly1descendant
- K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023 · cites it directly0descendants
- K230329F3D Interbody SystemCorelink, LLC · 2023 · 2 generations on0descendants
- K221542Galileo Vertebral Body Replacement DeviceBright Spine · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −11 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −10 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −9 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −8 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −7 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −6 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −5 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −4 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| −3 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… | Ldr Spine USA | 2016 | 1 |
| −2 | 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 | — |
| 0 (this device) | K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | Choicespine | 2019 | — |
| +1 | K202637 | F3D Corpectomy System | Corelink, LLC | 2020 | — |
| +1 | K192145 | Galileo Vertebral Body Replacement Device | Bright Spine | 2020 | — |
| +1 | K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR System | Carbofix Orthpedics, Ltd. | 2023 | — |
| +2 | K230329 | F3D Interbody System | Corelink, LLC | 2023 | — |
| +2 | K221542 | Galileo Vertebral Body Replacement Device | Bright Spine | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 23 | 0 |
| 2005 | 20 | 0 |
| 2006 | 10 | 0 |
| 2007 | 11 | 0 |
| 2008 | 31 | 1 |
| 2009 | 18 | 0 |
| 2010 | 11 | 0 |
| 2011 | 12 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2023 | 3 | 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.
1 device in this family has a Class I recall. 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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 |
|---|---|---|---|
| * | K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemSummary page 4…se in the thoracolumbar spine (T1-L5) and cervical spine (C2-T1) in Titanium (K162103), and additive manufactured titanium (K171686). Device Description: The ChoiceSpine HAWKEYETM Vertebral Body Replacement (VBR) System is composed of… | 2017 |
| * | K162315 | FORTIFY Corpectomy SpacersSummary page 5…cervical indication is equivalent to the primary predicate (K171686) and additional predicates Globus Medical Fortify® Corpectomy Spacers (K162315). The ChoiceSpine Vertebral Body Replacement (VBR) System has been cleared by the F… | 2017 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 17 companies; a new generation was cleared every 9 months on median.
- 29 of the 220 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K202637 (Corelink, LLC, 2020) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K171686.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The Choice Spine HAWKEYE™ Vertebral Body Replacement (VBR) Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5). Hawkeye (VBR) Spacers are also intended for use in the cervical spine (C2-T1). When used in the cervical spine (C2-T1), the HAWKEYE™ VBR devices are intended for use in the skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for…
Read the full statement (274 words)
The Choice Spine HAWKEYE™ Vertebral Body Replacement (VBR) Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5). Hawkeye (VBR) Spacers are also intended for use in the cervical spine (C2-T1).
When used in the cervical spine (C2-T1), the HAWKEYE™ VBR devices are intended for use in the skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
When used in the thoracolumbar spine (T1-L5), the HAWKEYE ™ VBR Spacers are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
These devices are intended to be used with FDA -cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e.,posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior 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/K183588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183588: Choice Spine Hawkeye Vertebral Body Replacement (VBR) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183588
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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