510(k) · Cleared
ClearedInfill Oblique Tlif 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 Jun 4, 2013 as substantially equivalent to K103729 (Pinnacle Spine Group, LLC, 2011) and 3 other predicates after a 159-day review. Its family tree reaches back 12 generations to 1984. 6 later devices descend from it.
- Decided
- Jun 4, 2013
- Review
- 159 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K841189 (1984). 23 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 2 generations backK103729 Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC · 2011
- 1 generation backK121733 Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC · 2012
- This deviceK124012 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 · 2 generations on · 3 of its ownK151184 InFill Interbody Fusion DevicesPinnacle Spine Group, LLC · 2015
- Descendant · 3 generations on · 2 of its ownK152259 InFill Interbody Fusion DevicePinnacle Spine Group, LLC · 2015
- Descendant · 2 generations on · 2 of its ownK150206 InFill Interbody Fusion DevicesPinnacle Spine Group, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK172349 InFill® Interbody Fusion DevicePinnacle Spine Group, LLC · 2017
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 8 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 7 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 6 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 5 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 4 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 3 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 2 generations backK103729 Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC · 2011
- 1 generation backK121733 Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC · 2012
- This deviceK124012 Infill Oblique Tlif DevicePinnacle Spine Group, LLC · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC · 2014 · cites it directly5descendants
- K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC · 2015 · 2 generations on3descendants
- K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC · 2015 · 3 generations on2descendants
- K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC · 2015 · 2 generations on2descendants
- K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −8 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −7 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −6 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −5 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −4 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −3 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −2 | K103729 | Infill Intervertebral Body Fusion Device | Pinnacle Spine Group, LLC | 2011 | — |
| −1 | K121733 | Infill Intervertebral Body Fusion Device | Pinnacle Spine Group, LLC | 2012 | — |
| 0 (this device) | 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 | — |
| +2 | K151184 | InFill Interbody Fusion Devices | Pinnacle Spine Group, LLC | 2015 | — |
| +3 | K152259 | InFill Interbody Fusion Device | Pinnacle Spine Group, LLC | 2015 | — |
| +2 | K150206 | InFill Interbody Fusion Devices | Pinnacle Spine Group, LLC | 2015 | — |
| +2 | K172349 | InFill® Interbody Fusion Device | Pinnacle Spine Group, LLC | 2017 | — |
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 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K103729 | Infill Intervertebral Body Fusion DeviceSummary page 1…rtebral Body Fusion Device NAME: ' DEVICE Class 1 CLASSIFICATION: REGULATION 888.3080 (product code: MAX) NUMBER PREDICATE DEVICES: InFill Intervertebral Body Spacer (K103729, K121733) Choice Spine ORIA Natura Spacer, (K073669) Nuvasive CoRoent TLIF (K120918) Substantially Equivalent To: The InFill™ T… | 2011 |
| * | K121733 | Infill Intervertebral Body Fusion DeviceSummary page 1…ody Fusion Device NAME: ' DEVICE Class 1 CLASSIFICATION: REGULATION 888.3080 (product code: MAX) NUMBER PREDICATE DEVICES: InFill Intervertebral Body Spacer (K103729, K121733) Choice Spine ORIA Natura Spacer, (K073669) Nuvasive CoRoent TLIF (K120918) Substantially Equivalent To: The InFill™ TLIF Obliq… | 2012 |
| * | K073669 | Oria Natura SpacerSummary page 1…LASSIFICATION: REGULATION 888.3080 (product code: MAX) NUMBER PREDICATE DEVICES: InFill Intervertebral Body Spacer (K103729, K121733) Choice Spine ORIA Natura Spacer, (K073669) Nuvasive CoRoent TLIF (K120918) Substantially Equivalent To: The InFill™ TLIF Oblique device is substantially equivalent in in… | 2008 |
| * | K120918 | Nuvasive Coroent Titanium SystemSummary page 1…080 (product code: MAX) NUMBER PREDICATE DEVICES: InFill Intervertebral Body Spacer (K103729, K121733) Choice Spine ORIA Natura Spacer, (K073669) Nuvasive CoRoent TLIF (K120918) Substantially Equivalent To: The InFill™ TLIF Oblique device is substantially equivalent in intended use, principal of operati… | 2012 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133721 | Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif… | 2014 | 5 |
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 29 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K133721 (Pinnacle Spine Group, LLC, 2014) has gone furthest, with 5 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. 2013, 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™ TLIF Oblique is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ TLIF Oblique is designed for use with autogenous bone graft to facilitate fusion. InFill™ TLIF Oblique 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…
Read the full statement (132 words)
InFill™ TLIF Oblique is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ TLIF Oblique is designed for use with autogenous bone graft to facilitate fusion. InFill™ TLIF Oblique 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™ TLIF Oblique 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K124012 · printed Nov 3, 2026
Cite this page
510(k) Report. “K124012: Infill Oblique Tlif Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K124012
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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