510(k) · Cleared
ClearedSpacevision Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Vision, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Dec 28, 2004 as substantially equivalent to K041888 (Signus Medizintechnik GmbH, 2004) and 3 other predicates after a 67-day review. Its family tree reaches back 6 generations to 1984. 1 of the 1,457 devices in its family, counting itself, has a Class I recall. 1,440 later devices descend from it.
- Decided
- Dec 28, 2004
- Review
- 67 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K841189 (1984). 16 ancestors in all. 1,440 later devices descend from it, 2 citing it directly. 1 of the 1,457 devices in this family, counting this one, has a Class I recall.
- 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 deviceK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- Descendant · cites it directly · 1,406 of its ownK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- Descendant · 2 generations on · 1,405 of its ownK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- Descendant · 3 generations on · 1,103 of its ownK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- Descendant · 4 generations on · 1,008 of its ownK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · 3 generations on · 932 of its ownK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
Showing 5 of 1,440 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 1,440 · See all- K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007 · cites it directly1,406descendants
- K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007 · 2 generations on1,405descendants
- K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · 3 generations on1,103descendants
- K100175Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010 · 4 generations on1,008descendants
- K080083Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · 3 generations on932descendants
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) | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| +1 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| +2 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| +3 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| +4 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +3 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 12 | 0 |
| 2009 | 5 | 0 |
| 2010 | 16 | 0 |
| 2011 | 29 | 0 |
| 2012 | 35 | 0 |
| 2013 | 42 | 0 |
| 2014 | 63 | 0 |
| 2015 | 68 | 0 |
| 2016 | 88 | 0 |
| 2017 | 107 | 0 |
| 2018 | 107 | 0 |
| 2019 | 107 | 0 |
| 2020 | 105 | 0 |
| 2021 | 104 | 1 |
| 2022 | 100 | 0 |
| 2023 | 134 | 0 |
| 2024 | 124 | 0 |
| 2025 | 101 | 0 |
| 2026 | 88 | 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? (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 |
|---|---|---|---|
| * | K041888 | Curved Peek Tetris Spinal ImplantSummary page 1…nal Intervertebral Body Fixation Orthosis DEVICE PRODUCT CODE: Product code: 87 MQP SUBSTANTIALLY EQUIVALENT DEVICES: K041888, Tetris'TM Spinal Implant, Signus Medizintechnik GMBH… | 2004 |
| * | K040928 | Expandable Peek VBR ImplantSummary page 1…LENT DEVICES: K041888, Tetris'TM Spinal Implant, Signus Medizintechnik GMBH K040928, Expandable PEEK VBR Implant, Interpore Cross International… | 2004 |
| * | K042268 | Ebi Cas Spine Spacer System Cleared while this submission was under review Summary page 1…K040928, Expandable PEEK VBR Implant, Interpore Cross International K042268, EBI CAS Spine Spacer System, EBI, L.P. K003709, Mesh Cage System, Surgical Dynamics TM DE… | 2004 |
| * | K003709 | Surgical Dynamics Mesh Cage SystemSummary page 1…Cross International K042268, EBI CAS Spine Spacer System, EBI, L.P. K003709, Mesh Cage System, Surgical Dynamics TM DEVICE DESCRIPTION AND INTENDED USE: The Spacevision cage implant is an oval shaped devi… | 2001 |
What descends from it? (1,440)
See all 1,4402 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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K062759 (Innovative Spinal Technologies, Inc., 2007) has gone furthest, with 1,406 descendants of its own.
- 10 other devices also cite its predicate K041888.
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 Spacevision Cage System is intended for use as partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body in the thoracolumbar spine (T1-5). The Spacevision Cage System is also indicated in the treatment of trauma/fractures of the thoracic and lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042930: Spacevision Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042930
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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