510(k) · Cleared
ClearedBox Peek VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Dec 22, 2006 as substantially equivalent to K043316 (Signus Medizintechnik GmbH, 2005) and 4 other predicates after a 148-day review. Its family tree reaches back 7 generations to 1984. 175 later devices descend from it.
- Decided
- Dec 22, 2006
- Review
- 148 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K841189 (1984). 23 ancestors in all. 175 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 5 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 4 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 2 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 1 generation backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- This deviceK062151 Box Peek VBR SystemInnovasis, Inc. · 2006
- Descendant · cites it directly · 172 of its ownK140142 Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP · 2014
- Descendant · 2 generations on · 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 · 3 generations on · 116 of its ownK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
- Descendant · 4 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
Showing 5 of 175 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 175 · See all- K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP · 2014 · cites it directly172descendants
- K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP · 2016 · 2 generations on171descendants
- 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 · 3 generations on116descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 4 generations on104descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −6 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −5 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −4 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −2 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −1 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| 0 (this device) | K062151 | Box Peek VBR System | Innovasis, Inc. | 2006 | — |
| +1 | K140142 | Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon) | Choicespine, LP | 2014 | — |
| +2 | 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 | — |
| +3 | K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System | Choicespine | 2017 | — |
| +4 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 10 | 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 MQP? 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? (5)
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 |
|---|---|---|---|
| * | K043316 | Rabea Spinal ImplantSummary page 1…Classification Name: Spinal intervertebral body fixation orthosis. Panel code: 87 Substantially Equivalent Devices: - K043316 - Rabea TM - Signus - K032064 - CPOD/LPOD… | 2005 |
| * | K032064 | Theken Cpod/Lpod Vertebral Body Replacement SystemSummary page 1…Panel code: 87 Substantially Equivalent Devices: - K043316 - Rabea TM - Signus - K032064 - CPOD/LPOD TM VBR System - Theken - K050553 -… | 2004 |
| * | K050553 | Novel VBR Spinal SystemSummary page 1…TM - Signus - K032064 - CPOD/LPOD TM VBR System - Theken - K050553 - Novel TM VBR Spinal System - Alphatec… | 2005 |
| * | K031757 | Peek Tetris Spinal ImplantSummary page 1…nal System - Alphatec TM - Signus Peek Tetris - K031757 - - K050449 - Quantum Vertebral Body Replacement - Quantum Orthopedics Device Description:… | 2003 |
| * | K050449 | Quantum Vertebral Body ReplacementSummary page 1…TM - Signus Peek Tetris - K031757 - - K050449 - Quantum Vertebral Body Replacement - Quantum Orthopedics Device Description: The Innovasis BOXTM Peek VBR System con… | 2005 |
What descends from it? (175)
See all 1752 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 22 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K140142 (Choicespine, LP, 2014) has gone furthest, with 172 descendants of its own.
- 4 other devices also cite its predicate K043316.
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.
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 Innovasis BoXTM peek VBR System is a vertebral body replacement indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis ExcellaTM Pedicle Screw System. The interior of the BoxTM system can be packed with allograft or autograft. BoxTM implants are intended to be used in pairs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062151: Box Peek 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/K062151
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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