510(k) · Cleared
ClearedParamount Intervertebral Body Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Spinal Technologies, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 11, 2007 as substantially equivalent to K062759 (Innovative Spinal Technologies, Inc., 2007) and 1 other predicate after a 71-day review. Its family tree reaches back 8 generations to 1984. 1 of the 1,429 devices in its family, counting itself, has a Class I recall. 1,405 later devices descend from it.
- Decided
- Oct 11, 2007
- Review
- 71 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K841189 (1984). 23 ancestors in all. 1,405 later devices descend from it, 8 citing it directly. 1 of the 1,429 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 2 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 1 generation backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- This deviceK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- Descendant · cites it directly · 1,103 of its ownK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- Descendant · 2 generations on · 1,008 of its ownK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · cites it directly · 932 of its ownK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- Descendant · 2 generations on · 907 of its ownK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- Descendant · cites it directly · 840 of its ownK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
Showing 5 of 1,405 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 1,405 · See all- K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · cites it directly1,103descendants
- K100175Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010 · 2 generations on1,008descendants
- K080083Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · cites it directly932descendants
- K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008 · 2 generations on907descendants
- K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008 · cites it directly840descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −2 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −1 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| 0 (this device) | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| +1 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| +2 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +1 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| +2 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| +1 | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 11 | 0 |
| 2009 | 4 | 0 |
| 2010 | 15 | 0 |
| 2011 | 26 | 0 |
| 2012 | 30 | 0 |
| 2013 | 36 | 0 |
| 2014 | 58 | 0 |
| 2015 | 67 | 0 |
| 2016 | 87 | 0 |
| 2017 | 105 | 0 |
| 2018 | 105 | 0 |
| 2019 | 107 | 0 |
| 2020 | 104 | 0 |
| 2021 | 103 | 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 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? (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 |
|---|---|---|---|
| * | K062759 | Paramount VBR SystemSummary page 1…l fixation, such as the ParamountTM Pedicle Screw System. PREDICATE DEVICES: The predicate devices include: Innovative Spinal Technologies, Inc. ParamountTM VBR System (K062759) and Centerpulse/ Zimmer Spine, Inc. BAKTM Interbody Fusion System (P950002). PERFORMANCE DATA: The mechanical test results based… | 2007 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 1…: The predicate devices include: Innovative Spinal Technologies, Inc. ParamountTM VBR System (K062759) and Centerpulse/ Zimmer Spine, Inc. BAKTM Interbody Fusion System (P950002). PERFORMANCE DATA: The mechanical test results based on ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02 demonstrate that the Para… | 1996 |
What descends from it? (1,405)
See all 1,4058 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073291 | Capstone Spinal System | 2008 | 1,103 |
| K080083 | Intrepid Spinal System | 2008 | 932 |
| K080401 | Shell Cage, Wave Cage, Loop Cage | 2008 | 840 |
| K073177 | Pioneer Intervertebral Fusion Device System | 2008 | 775 |
| K100820 | Wenzel Spine Varilift Interbody Fusion System | 2010 | 16 |
| K073502 | Vertebron VBR System | 2008 | 12 |
| K102322 | Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant… | 2011 | 6 |
| K100037 | Advanced Vertebral Solutions Express BFD | 2010 | 0 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K073291 (Medtronic Sofamor Danek USA, Inc., 2008) has gone furthest, with 1,103 descendants of its own.
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. 2007, 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 Paramount TM IBF device, when used with autogenous bone graft, is indicated for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and…
Read the full statement (122 words)
The Paramount TM IBF device, when used with autogenous bone graft, is indicated
for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous
levels from L2 to S1. These DDD patients may also have up to Grade 1
spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as
discogenic back pain with degeneration of the disc confirmed by history and
radiographic studies. These patients should be skeletally mature and have had six
months of non-operative treatment.
ParamountTM IBF devices are to be implanted via a direct posterior or transforaminal
approach. The ParamountTM IBF device may be used singly or in pairs in the
lumbosacral spine with or without supplemental fixation, such as the ParamountTM
Pedicle Screw System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072120 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072120: Paramount Intervertebral Body Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072120
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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