510(k) · Cleared
Recalled · 2009Intrepid Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 10, 2008 as substantially equivalent to K072253 (Synthes Spine Co.Lp, 2007) and 5 other predicates after a 90-day review. Its family tree reaches back 9 generations to 1984. 1 of the 963 devices in its family, counting itself, has a Class I recall. 932 later devices descend from it. It has been recalled 8 times.
- Decided
- Apr 10, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 8
- Predicates
- 6
Its longest line of descent runs back 9 generations to K841189 (1984). 30 ancestors in all. 932 later devices descend from it, 3 citing it directly. 1 of the 963 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 2 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- This deviceK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008
- Descendant · cites it directly · 907 of its ownK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- Descendant · 2 generations on · 834 of its ownK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- Descendant · cites it directly · 753 of its ownK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- Descendant · cites it directly · 719 of its ownK091813 Intrepid Spinal SystemMedtronic Sofamor Danek · 2009
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 3 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 2 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- This deviceK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008
Showing 5 of 932 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 932 · See all- K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008 · cites it directly907descendants
- K083475Lucent MagnumSpinal Elements, Inc. · 2009 · 2 generations on834descendants
- K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · cites it directly753descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 2 generations on744descendants
- K091813Intrepid Spinal SystemMedtronic Sofamor Danek · 2009 · cites it directly719descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −3 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −2 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −1 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| 0 (this device) | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | — |
| +1 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| +2 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| +1 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| +2 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| +1 | K091813 | Intrepid Spinal System | Medtronic Sofamor Danek | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 8 | 0 |
| 2014 | 21 | 0 |
| 2015 | 31 | 0 |
| 2016 | 50 | 0 |
| 2017 | 64 | 0 |
| 2018 | 69 | 0 |
| 2019 | 81 | 0 |
| 2020 | 95 | 0 |
| 2021 | 75 | 1 |
| 2022 | 76 | 0 |
| 2023 | 93 | 0 |
| 2024 | 95 | 0 |
| 2025 | 79 | 0 |
| 2026 | 71 | 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? (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 |
|---|---|---|---|
| * | K072253 | Synfix-LR SpacerSummary page 2…ults was provided which demonstrated that the subject INTREPIDTM Spinal System is substantially equivalent to the SynFIX-LR Spacer (K072253, SE 10/12/07, Synthes Spine), the LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek… | 2007 |
| * | P970015 | Inter Fix Threaded Fusion DeviceSummary page 2…tantially equivalent to the SynFIX-LR Spacer (K072253, SE 10/12/07, Synthes Spine), the LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03), the BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03), the RAY®… | 1999 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 2…Synthes Spine), the LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03), the BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03), the RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03), the Lumbar… | 1996 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 2…Medtronic Sofamor Danek, Approved 9/10/03), the BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03), the RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03), the Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05) and the PARAMOUNT Interverte… | 1996 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 2…Cage (P950002, Zimmer Spine, Approved 7/8/03), the RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03), the Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05) and the PARAMOUNT Intervertebral Body Fusion Device (K072120, Innovative… | 1999 |
| * | K072120 | Paramount Intervertebral Body Fusion DeviceSummary page 2…(P950019, Stryker, Approved 9/4/03), the Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05) and the PARAMOUNT Intervertebral Body Fusion Device (K072120, Innovative Spinal Technologies, SE 10/11/07). DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2007 |
What descends from it? (932)
See all 9323 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2009 | Not classified | Z-1797-2009 | Device Design | The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment. |
| Feb 6, 2009 | Not classified | Z-1798-2009 | Device Design | The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment. |
| Feb 6, 2009 | Not classified | Z-1803-2009 | Device Design | The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment. |
| Feb 6, 2009 | Not classified | Z-1800-2009 | Device Design | The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment. |
| Feb 6, 2009 | Not classified | Z-1799-2009 | Device Design | The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment. |
| Feb 6, 2009 | Not classified | Z-1796-2009 | Device Design | The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment. |
| Feb 6, 2009 | Not classified | Z-1802-2009 | Device Design | The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment. |
| Feb 6, 2009 | Not classified | Z-1801-2009 | Device Design | The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment. |
The 5 latest of 8 recalls; the web page lists all.
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 24 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 5 of the 30 ancestors have a recall of any class.
- Of its descendants, K073109 (Surgicraft, Ltd., 2008) has gone furthest, with 907 descendants of its own.
- 27 other devices also cite its predicate K072253.
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. 2008, 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 INTREPIDTM Spinal System is indicated for use with autogenous bone graft 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 levels. 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…
Read the full statement (148 words)
The INTREPIDTM Spinal System is indicated for use with autogenous bone graft 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 levels. 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. These implants may be implanted via a laparoscopic or an open anterior approach. The INTREPIDTM interbody device is intended to be used with the three titanium alloy screws which accompany the implant. If the physician chooses to use less than three, or none of the provided screws, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080083 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080083: Intrepid Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080083
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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