510(k) · Cleared
ClearedSpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinevision S.A. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 4, 2016 as substantially equivalent to K082801 (Us Spine, 2008) and 2 other predicates after a 125-day review. Its family tree reaches back 11 generations to 1984. 13 later devices descend from it.
- Decided
- May 4, 2016
- Review
- 125 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K841189 (1984). 29 ancestors in all. 13 later devices descend from it, 6 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 1 generation backK082801 Phantom Plus Cage SystemUs Spine · 2008
- This deviceK153783 SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A. · 2016
- Descendant · cites it directly · 6 of its ownK192026 Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd. · 2019
- Descendant · 2 generations on · 5 of its ownK202872 Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd. · 2021
- Descendant · 2 generations on · 4 of its ownK213980 Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd. · 2022
- Descendant · 3 generations on · 3 of its ownK230708 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion…Gbs Commonwealth Co., Ltd. · 2023
- Descendant · 4 generations on · 2 of its ownK232822 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion…Gbs Commonwealth Co., Ltd. · 2023
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 1 generation backK082801 Phantom Plus Cage SystemUs Spine · 2008
- This deviceK153783 SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A. · 2016
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd. · 2019 · cites it directly6descendants
- K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd. · 2021 · 2 generations on5descendants
- K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd. · 2022 · 2 generations on4descendants
- K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd. · 2023 · 3 generations on3descendants
- K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd. · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
| −1 | K082801 | Phantom Plus Cage System | Us Spine | 2008 | — |
| 0 (this device) | K153783 | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF | Spinevision S.A. | 2016 | — |
| +1 | K192026 | Peridot Intervertebral body fusion System | Gbs Commonwealth Co., Ltd. | 2019 | — |
| +2 | K202872 | Prase PEEK Anterior Cervical Interbody Spacer | Gbs Commonwealth Co., Ltd. | 2021 | — |
| +2 | K213980 | Peridot Spinal Interbody System | Gbs Commonwealth Co., Ltd. | 2022 | — |
| +3 | K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)… | Gbs Commonwealth Co., Ltd. | 2023 | — |
| +4 | K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)… | Gbs Commonwealth Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K082801 | Phantom Plus Cage SystemSummary page 4…II Product Code MAX CFR section 888.3080 Device panel Orthopedic Primary Predicate K082801 Phantom PLIF manufactured by US Spine Legally marketed Additional Predicates predicate devices… | 2008 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 4…K082801 Phantom PLIF manufactured by US Spine Legally marketed Additional Predicates predicate devices P950002 BAK-L manufactured by Zimmer P960025 Brantigan Cage manufactured by DePuy Spine The S… | 1996 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 4…US Spine Legally marketed Additional Predicates predicate devices P950002 BAK-L manufactured by Zimmer P960025 Brantigan Cage manufactured by DePuy Spine The SpaceVision® PLIF system (Posterior Lumbar Interbody Fusion)… | 1999 |
What descends from it? (13)
See all 136 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 32 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K192026 (Gbs Commonwealth Co., Ltd., 2019) has gone furthest, with 6 descendants of its own.
- 12 other devices also cite its predicate K082801.
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. 2016, 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?
The SpaceVision® PLIF (Posterior Lumbar Interbody Fusion), the SpaceVision® TLIF (Transforaminal Lumbar Interbody Fusion) and SpaceVision® OLIF (Oblique Lumbar Interbody Fusion) systems are intervertebral body fusion devices indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc…
Read the full statement (162 words)
The SpaceVision® PLIF (Posterior Lumbar Interbody Fusion), the SpaceVision® TLIF (Transforaminal Lumbar Interbody Fusion) and SpaceVision® OLIF (Oblique Lumbar Interbody Fusion) systems are intervertebral body fusion devices indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 months of non-operative treatment prior to treatment with SpaceVision® PLIF, SpaceVision® TLIF or SpaceVision® OLIF systems. These devices are to be filled with autogenous bone graft material. These devices can be implanted via posterior or transforaminal approaches. SpaceVision® PLIF, SpaceVision® TLIF or SpaceVision® OLIF systems must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153783 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153783: SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153783
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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