510(k) · Cleared
ClearedSpinal Usa VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal USA · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 16, 2008 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 4 other predicates after a 171-day review. Its family tree reaches back 5 generations to 2001. 13 later devices descend from it.
- Decided
- Oct 16, 2008
- Review
- 171 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K010530 (2001). 12 ancestors in all, the oldest P950002 (1996). 13 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 4 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 3 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 2 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 1 generation backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- This deviceK081196 Spinal Usa VBR SystemSpinal USA · 2008
- Descendant · cites it directly · 10 of its ownK110442 Nanovis Intervertebral Body Fusion SystemNanovis, LLC · 2011
- Descendant · 2 generations on · 9 of its ownK140280 ForticoreNanovis, LLC · 2014
- Descendant · 2 generations on · 5 of its ownK161485 Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC · 2016
- Descendant · 2 generations on · 4 of its ownK160874 Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC · 2016
- Descendant · 3 generations on · 3 of its ownK171312 FortiCore®Nanovis, LLC · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC · 2011 · cites it directly10descendants
- K140280ForticoreNanovis, LLC · 2014 · 2 generations on9descendants
- K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC · 2016 · 2 generations on5descendants
- K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC · 2016 · 2 generations on4descendants
- K171312FortiCore®Nanovis, LLC · 2018 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −4 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −3 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −2 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −1 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| 0 (this device) | K081196 | Spinal Usa VBR System | Spinal USA | 2008 | — |
| +1 | K110442 | Nanovis Intervertebral Body Fusion System | Nanovis, LLC | 2011 | — |
| +2 | K140280 | Forticore | Nanovis, LLC | 2014 | — |
| +2 | K161485 | Nanovis Intervertebral Body Fusion System and Forticore (R) | Nanovis, LLC | 2016 | — |
| +2 | K160874 | Nanovis Intervertebral Body Fusion System and FortiCore® | Nanovis, LLC | 2016 | — |
| +3 | K171312 | FortiCore® | Nanovis, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (5)
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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…s based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture. The predicate devices are Depuy Spine-Brantigan I/F Cage (P960025), Synthes Synfix Spacer (K072253), Medicrea Technologies-Implex Spacer (K072226), Stryker Spine-Avs PL Peek Spacer (K073470), Str… | 1999 |
| * | K072253 | Synfix-LR SpacerSummary page 1…ded use, indications, anatomic sites, performance and material of manufacture. The predicate devices are Depuy Spine-Brantigan I/F Cage (P960025), Synthes Synfix Spacer (K072253), Medicrea Technologies-Implex Spacer (K072226), Stryker Spine-Avs PL Peek Spacer (K073470), Stryker Spine-Avs PL Peek Spacer (K0… | 2007 |
| * | K072226 | Impix SpacerSummary page 1…ce and material of manufacture. The predicate devices are Depuy Spine-Brantigan I/F Cage (P960025), Synthes Synfix Spacer (K072253), Medicrea Technologies-Implex Spacer (K072226), Stryker Spine-Avs PL Peek Spacer (K073470), Stryker Spine-Avs PL Peek Spacer (K080758) DEPARTMENT OF HEALTH &… | 2007 |
| * | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXXSummary page 1…e devices are Depuy Spine-Brantigan I/F Cage (P960025), Synthes Synfix Spacer (K072253), Medicrea Technologies-Implex Spacer (K072226), Stryker Spine-Avs PL Peek Spacer (K073470), Stryker Spine-Avs PL Peek Spacer (K080758) DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2008 |
| * | K080758 | Avs PL Peek Spacers, Models 48351 and 48353Summary page 1…(P960025), Synthes Synfix Spacer (K072253), Medicrea Technologies-Implex Spacer (K072226), Stryker Spine-Avs PL Peek Spacer (K073470), Stryker Spine-Avs PL Peek Spacer (K080758) DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2008 |
What descends from it? (13)
See all 132 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 7 years and passes through 5 companies; a new generation was cleared every 6 months on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K110442 (Nanovis, LLC, 2011) has gone furthest, with 10 descendants of its own.
- 98 other devices also cite its predicate P960025.
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 Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF and TLIF system. Two devices are used per intervertebral space for the PLIF system. The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are intended for use at either one level or two…
Read the full statement (152 words)
The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF and TLIF system. Two devices are used per intervertebral space for the PLIF system.
The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081196: Spinal Usa VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081196
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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