510(k) · Cleared
ClearedQuantum Vertebral Body Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantum Orthopedics, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Jul 7, 2005 as substantially equivalent to K040284 (Globus Medical, Inc., 2004) and 5 other predicates after a 135-day review. Its family tree reaches back 6 generations to 1984. 197 later devices descend from it.
- Decided
- Jul 7, 2005
- Review
- 135 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K841189 (1984). 18 ancestors in all. 197 later devices descend from it, 7 citing it directly.
- Root · 6 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 4 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 3 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 2 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 1 generation backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- This deviceK050449 Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc. · 2005
- Descendant · cites it directly · 175 of its ownK062151 Box Peek VBR SystemInnovasis, Inc. · 2006
- Descendant · 2 generations on · 172 of its ownK140142 Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP · 2014
- Descendant · 3 generations on · 171 of its ownK153107 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- Descendant · 3 generations on · 161 of its ownK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- Descendant · 4 generations on · 116 of its ownK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
Showing 5 of 197 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 197 · See all- K062151Box Peek VBR SystemInnovasis, Inc. · 2006 · cites it directly175descendants
- K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP · 2014 · 2 generations on172descendants
- K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP · 2016 · 3 generations on171descendants
- K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP · 2016 · 3 generations on161descendants
- K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017 · 4 generations on116descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −5 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −4 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −3 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −2 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −1 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| 0 (this device) | K050449 | Quantum Vertebral Body Replacement | Quantum Orthopedics, Inc. | 2005 | — |
| +1 | K062151 | Box Peek VBR System | Innovasis, Inc. | 2006 | — |
| +2 | K140142 | Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon) | Choicespine, LP | 2014 | — |
| +3 | K153107 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| +3 | K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| +4 | K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System | Choicespine | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 11 | 0 |
| 2020 | 12 | 0 |
| 2021 | 13 | 0 |
| 2022 | 22 | 0 |
| 2023 | 19 | 0 |
| 2024 | 31 | 0 |
| 2025 | 33 | 0 |
| 2026 | 29 | 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? (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 |
|---|---|---|---|
| * | K040284 | Sustain Radiolucent SpacerSummary page 2…r autograft. SubstantialEquivalence The Quantum Vertebral Body Replacement was shown to be substantially equivalent to Sustain Radiolucent Spacer (Globus Medical, Inc., K040284), CadeneeTM and Traxis TM (Spinal Concepts, K033517), PEEK Tetris TM (Signus Medical LLC, K031757 and K041888), STALIF TM TT (Sur… | 2004 |
| * | K033517 | Spinal Concepts Inc. Cadence and TraxisSummary page 2…tebral Body Replacement was shown to be substantially equivalent to Sustain Radiolucent Spacer (Globus Medical, Inc., K040284), CadeneeTM and Traxis TM (Spinal Concepts, K033517), PEEK Tetris TM (Signus Medical LLC, K031757 and K041888), STALIF TM TT (Surgicraft, K041617), and SynMesh (Synthes, K003275).… | 2004 |
| * | K031757 | Peek Tetris Spinal ImplantSummary page 2…ntially equivalent to Sustain Radiolucent Spacer (Globus Medical, Inc., K040284), CadeneeTM and Traxis TM (Spinal Concepts, K033517), PEEK Tetris TM (Signus Medical LLC, K031757 and K041888), STALIF TM TT (Surgicraft, K041617), and SynMesh (Synthes, K003275). PerformanceData Mechanical testing indicates t… | 2003 |
| * | K041888 | Curved Peek Tetris Spinal ImplantSummary page 2…valent to Sustain Radiolucent Spacer (Globus Medical, Inc., K040284), CadeneeTM and Traxis TM (Spinal Concepts, K033517), PEEK Tetris TM (Signus Medical LLC, K031757 and K041888), STALIF TM TT (Surgicraft, K041617), and SynMesh (Synthes, K003275). PerformanceData Mechanical testing indicates that the Quan… | 2004 |
| * | K041617 | Stalif TTSummary page 2…(Globus Medical, Inc., K040284), CadeneeTM and Traxis TM (Spinal Concepts, K033517), PEEK Tetris TM (Signus Medical LLC, K031757 and K041888), STALIF TM TT (Surgicraft, K041617), and SynMesh (Synthes, K003275). PerformanceData Mechanical testing indicates that the Quantum Vertebral Body Replacement is ca… | 2004 |
| * | K003275 | Synthes Synmesh Spacer SystemSummary page 2…, CadeneeTM and Traxis TM (Spinal Concepts, K033517), PEEK Tetris TM (Signus Medical LLC, K031757 and K041888), STALIF TM TT (Surgicraft, K041617), and SynMesh (Synthes, K003275). PerformanceData Mechanical testing indicates that the Quantum Vertebral Body Replacement is capable of performing in accordanc… | 2001 |
What descends from it? (197)
See all 1977 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 21 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K062151 (Innovasis, Inc., 2006) has gone furthest, with 175 descendants of its own.
- 9 other devices also cite its predicate K040284.
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 Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050449: Quantum Vertebral Body Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050449
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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