510(k) · Cleared
ClearedInfill Intervertebral Body 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 Jul 13, 2012 as substantially equivalent to K103729 (Pinnacle Spine Group, LLC, 2011) after a 30-day review. Its family tree reaches back 11 generations to 1984. 21 later devices descend from it.
- Decided
- Jul 13, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K841189 (1984). 20 ancestors in all. 21 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 1 generation backK103729 Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC · 2011
- This deviceK121733 Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC · 2012
- Descendant · cites it directly · 13 of its ownK130461 Stalif XCentinel Spine, Inc. · 2013
- Descendant · 2 generations on · 12 of its ownK173347 STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique…Centinel Spine, Inc. · 2018
- Descendant · cites it directly · 6 of its ownK124012 Infill Oblique Tlif DevicePinnacle Spine Group, LLC · 2013
- Descendant · cites it directly · 5 of its ownK133721 Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour…Pinnacle Spine Group, LLC · 2014
- Descendant · 3 generations on · 4 of its ownK201453 Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 7 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 6 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 5 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 1 generation backK103729 Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC · 2011
- This deviceK121733 Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC · 2012
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K130461Stalif XCentinel Spine, Inc. · 2013 · cites it directly13descendants
- K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc. · 2018 · 2 generations on12descendants
- K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC · 2013 · cites it directly6descendants
- K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC · 2014 · cites it directly5descendants
- K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −7 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −6 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −5 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −3 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −2 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −1 | K103729 | Infill Intervertebral Body Fusion Device | Pinnacle Spine Group, LLC | 2011 | — |
| 0 (this device) | K121733 | Infill Intervertebral Body Fusion Device | Pinnacle Spine Group, LLC | 2012 | — |
| +1 | K130461 | Stalif X | Centinel Spine, Inc. | 2013 | — |
| +2 | K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX… | Centinel Spine, Inc. | 2018 | — |
| +1 | K124012 | Infill Oblique Tlif Device | Pinnacle Spine Group, LLC | 2013 | — |
| +1 | K133721 | Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill… | Pinnacle Spine Group, LLC | 2014 | — |
| +3 | K201453 | Fortilink Cages with TiPlus Technology | Paradigm Spine GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K103729 | Infill Intervertebral Body Fusion DeviceSummary page 1…Class 2, per 21 CER 888.3080 CLASSIFICATION: PRODUCT CODE MAX PREDICATE DEVICES: InFiITm IntervertLebral Body Fusion Device (K103729) Substantially Equivalent To: The modified InFilTM Intervertebral Body Fusion Device is substantially equivalent in intende… | 2011 |
What descends from it? (21)
See all 213 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 28 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K130461 (Centinel Spine, Inc., 2013) has gone furthest, with 13 descendants of its own.
- 3 other devices also cite its predicate K103729.
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. 2012, 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?
InFil is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFil is designed for use with autogenous bone graft to facilitate fusion. InFil 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…
Read the full statement (124 words)
InFil is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFil is designed for use with autogenous bone graft to facilitate fusion. InFil 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. InFil is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121733: Infill Intervertebral Body 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/K121733
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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