510(k) · Cleared
ClearedNeoFuse HA Enhanced PLIF/TLIF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ht Medical, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 6, 2016 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 3 other predicates after a 141-day review. Its family tree reaches back 13 generations to 1984. 50 later devices descend from it.
- Decided
- May 6, 2016
- Review
- 141 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K841189 (1984). 72 ancestors in all. 50 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 2 generations backK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 1 generation backK150321 EVOS Lumbar Interbody SystemCutting Edge Spine, LLC · 2015
- This deviceK153615 NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC · 2016
- Descendant · cites it directly · 49 of its ownK170318 NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC · 2017
- Descendant · 2 generations on · 37 of its ownK192115 SABLE Expandable SpacerGlobus Medical, Inc. · 2020
- Descendant · 3 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
- Descendant · 4 generations on · 6 of its ownK241846 E3D™-C Interbody SystemEvolution Spine · 2024
- Descendant · 4 generations on · 5 of its ownK243635 aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 3 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 2 generations backK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 1 generation backK150321 EVOS Lumbar Interbody SystemCutting Edge Spine, LLC · 2015
- This deviceK153615 NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC · 2016
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC · 2017 · cites it directly49descendants
- K192115SABLE Expandable SpacerGlobus Medical, Inc. · 2020 · 2 generations on37descendants
- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 3 generations on23descendants
- K241846E3D™-C Interbody SystemEvolution Spine · 2024 · 4 generations on6descendants
- K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −3 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −2 | K120368 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −1 | K150321 | EVOS Lumbar Interbody System | Cutting Edge Spine, LLC | 2015 | — |
| 0 (this device) | K153615 | NeoFuse HA Enhanced PLIF/TLIF | Ht Medical, LLC | 2016 | — |
| +1 | K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | Ht Medical, LLC | 2017 | — |
| +2 | K192115 | SABLE Expandable Spacer | Globus Medical, Inc. | 2020 | — |
| +3 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
| +4 | K241846 | E3D™-C Interbody System | Evolution Spine | 2024 | — |
| +4 | K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 10 | 0 |
| 2024 | 7 | 0 |
| 2025 | 10 | 0 |
| 2026 | 12 | 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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 4…Device The interbody fusion system is substantially equivalent to legally marketed predicate devices. The primary predicate devices is Depuy/AcroMed Lumbar I/F Cage per P960025, with additional predicates including Meditech Spine Talos-C per K142345, SpineFrontier, Inc., Arena-C HA PEEK Cervical Interbody… | 1999 |
| * | K142345 | Talos-C (HA) Cervical Intervertebral Body Fusion DevicesSummary page 4…y marketed predicate devices. The primary predicate devices is Depuy/AcroMed Lumbar I/F Cage per P960025, with additional predicates including Meditech Spine Talos-C per K142345, SpineFrontier, Inc., Arena-C HA PEEK Cervical Interbody Fusion Device per K142026, and Cutting Edge Spine, LLC’s EVOS Lumbar Int… | 2015 |
| * | K142026 | Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSummary page 4…I/F Cage per P960025, with additional predicates including Meditech Spine Talos-C per K142345, SpineFrontier, Inc., Arena-C HA PEEK Cervical Interbody Fusion Device per K142026, and Cutting Edge Spine, LLC’s EVOS Lumbar Interbody System per K150321.… | 2014 |
| * | K150321 | EVOS Lumbar Interbody SystemSummary page 4…ne Talos-C per K142345, SpineFrontier, Inc., Arena-C HA PEEK Cervical Interbody Fusion Device per K142026, and Cutting Edge Spine, LLC’s EVOS Lumbar Interbody System per K150321. Page 2 of 2 HT Medical, LLC… | 2015 |
What descends from it? (50)
See all 501 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | 2017 | 49 |
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 32 years and passes through 11 companies; a new generation was cleared every 1.4 years on median.
- 10 of the 72 ancestors have a recall of any class.
- Of its descendants, K170318 (Ht Medical, LLC, 2017) has gone furthest, with 49 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. 2016, 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?
When used as a Lumbar Interbody Fusion device, NeoFuse is indicated for use in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. Lumbar DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least six (6) months of prior non-operative treatment prior to treatment with the device.
The devices must be used with supplemental fixation and must be used with autograft / autologous bone graft to facilitate fusion for each spinal region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153615: NeoFuse HA Enhanced PLIF/TLIF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153615
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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