510(k) · Cleared
ClearedInFill® Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pinnacle Spine Group, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 14, 2017 as substantially equivalent to K152259 (Pinnacle Spine Group, LLC, 2015) and 3 other predicates after a 133-day review. Its family tree reaches back 16 generations to 1984. 1 later device descends from it.
- Decided
- Dec 14, 2017
- Review
- 133 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K841189 (1984). 119 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK133721 Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour…Pinnacle Spine Group, LLC · 2014
- 2 generations backK151184 InFill Interbody Fusion DevicesPinnacle Spine Group, LLC · 2015
- 1 generation backK152259 InFill Interbody Fusion DevicePinnacle Spine Group, LLC · 2015
- This deviceK172349 InFill® Interbody Fusion DevicePinnacle Spine Group, LLC · 2017
- Descendant · cites it directly · 0 of its ownK202820 Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd. · 2020
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 12 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 11 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 10 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 9 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 8 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 7 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 6 generations backK103729 Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC · 2011
- 5 generations backK121733 Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC · 2012
- 4 generations backK124012 Infill Oblique Tlif DevicePinnacle Spine Group, LLC · 2013
- 3 generations backK133721 Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour…Pinnacle Spine Group, LLC · 2014
- 2 generations backK151184 InFill Interbody Fusion DevicesPinnacle Spine Group, LLC · 2015
- 1 generation backK152259 InFill Interbody Fusion DevicePinnacle Spine Group, LLC · 2015
- This deviceK172349 InFill® Interbody Fusion DevicePinnacle Spine Group, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −12 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −11 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −10 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −9 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −8 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −7 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −6 | K103729 | Infill Intervertebral Body Fusion Device | Pinnacle Spine Group, LLC | 2011 | — |
| −5 | K121733 | Infill Intervertebral Body Fusion Device | Pinnacle Spine Group, LLC | 2012 | — |
| −4 | K124012 | Infill Oblique Tlif Device | Pinnacle Spine Group, LLC | 2013 | — |
| −3 | K133721 | Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill… | Pinnacle Spine Group, LLC | 2014 | — |
| −2 | K151184 | InFill Interbody Fusion Devices | Pinnacle Spine Group, LLC | 2015 | — |
| −1 | K152259 | InFill Interbody Fusion Device | Pinnacle Spine Group, LLC | 2015 | — |
| 0 (this device) | K172349 | InFill® Interbody Fusion Device | Pinnacle Spine Group, LLC | 2017 | — |
| +1 | K202820 | Australis Anterior Lumbar Cage System | Prism Surgical Designs Pty, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 14 | 0 |
| 2004 | 14 | 0 |
| 2005 | 5 | 0 |
| 2007 | 9 | 0 |
| 2008 | 13 | 0 |
| 2009 | 8 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (4)
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 |
|---|---|---|---|
| * | K152259 | InFill Interbody Fusion DeviceSummary page 6…dicate Devices 510k Trade or Proprietary or Model Manufacturer Predicate Type Number Name K152259 InFill® V2 Lateral Pinnacle Spine Group Primary K150206 InFill® Interbody Fusion Device Pin… | 2015 |
| * | K150206 | InFill Interbody Fusion DevicesSummary page 6…Manufacturer Predicate Type Number Name K152259 InFill® V2 Lateral Pinnacle Spine Group Primary K150206 InFill® Interbody Fusion Device Pinnacle Spine Group Additional K133721 InFill® Interbody Fusion Device… | 2015 |
| * | K133721 | Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Summary page 6…152259 InFill® V2 Lateral Pinnacle Spine Group Primary K150206 InFill® Interbody Fusion Device Pinnacle Spine Group Additional K133721 InFill® Interbody Fusion Device Pinnacle Spine Group Additional K150321 EVOS Lumbar Interbody System… | 2014 |
| * | K150321 | EVOS Lumbar Interbody SystemSummary page 6…206 InFill® Interbody Fusion Device Pinnacle Spine Group Additional K133721 InFill® Interbody Fusion Device Pinnacle Spine Group Additional K150321 EVOS Lumbar Interbody System Cutting Edge Spine Additional PERFORMANCE DATA The InFill® V2 Lateral Device (w… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202820 | Australis Anterior Lumbar Cage System | 2020 | 0 |
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 33 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 119 ancestors have a recall of any class.
- Of its descendants, K202820 (Prism Surgical Designs Pty, Ltd., 2020) has gone furthest, with 0 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. 2017, 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?
InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is 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…
Read the full statement (156 words)
InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is 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 devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and lateral.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172349: InFill® Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172349
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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