510(k) · Cleared
Recalled · Class II · 2013S-Lif Intervertebral Body Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinefrontier, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 30, 2010 as substantially equivalent to K072289 (Spinefrontier, Inc., 2007) and 2 other predicates after a 289-day review. Its family tree reaches back 2 generations to 1996. 15 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 30, 2010
- Review
- 289 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 2 generations to P950002 (1996). 6 ancestors in all. 15 later devices descend from it, 1 citing it directly.
- Root · 2 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 1 generation backK072289 Spinefrontier Dorado VBRSpinefrontier, Inc. · 2007
- This deviceK092815 S-Lif Intervertebral Body Fusion DeviceSpinefrontier, Inc. · 2010
- Descendant · cites it directly · 14 of its ownK111553 Spinefrontier Lumbar Ibf SystemSpinefrontier, Inc. · 2011
- Descendant · 2 generations on · 8 of its ownK160976 Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · 3 generations on · 6 of its ownK170512 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · 2 generations on · 4 of its ownK142504 SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK201367 FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K111553Spinefrontier Lumbar Ibf SystemSpinefrontier, Inc. · 2011 · cites it directly14descendants
- K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017 · 2 generations on8descendants
- K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017 · 3 generations on6descendants
- K142504SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2015 · 2 generations on4descendants
- K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −1 | K072289 | Spinefrontier Dorado VBR | Spinefrontier, Inc. | 2007 | — |
| 0 (this device) | K092815 | S-Lif Intervertebral Body Fusion Device | Spinefrontier, Inc. | 2010 | — |
| +1 | K111553 | Spinefrontier Lumbar Ibf System | Spinefrontier, Inc. | 2011 | — |
| +2 | K160976 | Altus Spine Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +3 | K170512 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +2 | K142504 | SpineFrontier Lumbar Interbody Fusion Device System | Spinefrontier, Inc. | 2015 | — |
| +3 | K201367 | FlareHawk TiHawk9 Interbody Fusion System | Integrity Implants, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K072289 | Spinefrontier Dorado VBRSummary page 1…Lumbar, (21 CFR 888.3080), Class II Product Code: MAX 3. Predicate Devices K072289 - SpineFrontier Inc., Dorado Intervertebral Body Cage K071795 - Nuvasive CoRoent System K072791 - Synth… | 2007 |
| * | K071795 | Nuvasive Coroent SystemSummary page 1…Product Code: MAX 3. Predicate Devices K072289 - SpineFrontier Inc., Dorado Intervertebral Body Cage K071795 - Nuvasive CoRoent System K072791 - Synthes Spine Oracle Spacer 4. Device Description The S-… | 2007 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 1…AX 3. Predicate Devices K072289 - SpineFrontier Inc., Dorado Intervertebral Body Cage K071795 - Nuvasive CoRoent System K072791 - Synthes Spine Oracle Spacer 4. Device Description The S-LIFTM Intervertebral Body Fusion Device is a sp… | 2007 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111553 | Spinefrontier Lumbar Ibf System | 2011 | 14 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2013 | Class II | Z-0274-2014 | Device Design | Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades. |
| May 24, 2013 | Class II | Z-1665-2013 | Device Design | The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small. |
| May 17, 2013 | Class II | Z-1664-2013 | Component design/selection | The S-LIFT Instrument Case contained a bracket with peeling nylon coating. |
| Aug 29, 2012 | Class II | Z-1932-2013 | Process design | During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. |
| Aug 22, 2012 | Class II | Z-0417-2013 | Labeling design | When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient.… |
| Dec 23, 2011 | Class II | Z-1565-2014 | Device Design | It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K111553 (Spinefrontier, Inc., 2011) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K072289.
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. 2010, 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 S-LlF TM Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DIDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved…
Read the full statement (131 words)
The S-LlF TM Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DIDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).
The SpineFrontier S-LIF TM Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation systemn(s) cleared for use in the lumbar spine.
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092815 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092815: S-Lif 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/K092815
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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