510(k) · Cleared
ClearedBonebac T-Plif Intervertebral Body Fusion Device System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thompson Mis, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 26, 2011 as substantially equivalent to K100042 (Difusion Technologies, 2010) and 4 other predicates after a 147-day review. Its family tree reaches back 8 generations to 1984. 1 of the 796 devices in its family, counting itself, has a Class I recall. 762 later devices descend from it.
- Decided
- Oct 26, 2011
- Review
- 147 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K841189 (1984). 33 ancestors in all. 762 later devices descend from it, 1 citing it directly. 1 of the 796 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 2 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 1 generation backK100042 Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies · 2010
- This deviceK111512 Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc. · 2011
- Descendant · cites it directly · 761 of its ownK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 2 generations on · 723 of its ownK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 2 generations on · 709 of its ownK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- Descendant · 3 generations on · 480 of its ownK141896 Coroent SystemNu Vasive, Incorporated · 2014
- Descendant · 4 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Showing 5 of 762 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 762 · See all- K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · cites it directly761descendants
- K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on723descendants
- K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013 · 2 generations on709descendants
- K141896Coroent SystemNu Vasive, Incorporated · 2014 · 3 generations on480descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 4 generations on479descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −2 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −1 | K100042 | Difusion Technologies Xiphos Interbody Fusion System | Difusion Technologies | 2010 | — |
| 0 (this device) | K111512 | Bonebac T-Plif Intervertebral Body Fusion Device System | Thompson Mis, Inc. | 2011 | — |
| +1 | K120368 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +2 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +2 | K123027 | Capstone (R) Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
| +3 | K141896 | Coroent System | Nu Vasive, Incorporated | 2014 | — |
| +4 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 12 | 0 |
| 2015 | 13 | 0 |
| 2016 | 29 | 0 |
| 2017 | 44 | 0 |
| 2018 | 54 | 0 |
| 2019 | 64 | 0 |
| 2020 | 78 | 0 |
| 2021 | 67 | 1 |
| 2022 | 71 | 0 |
| 2023 | 88 | 0 |
| 2024 | 94 | 0 |
| 2025 | 75 | 0 |
| 2026 | 66 | 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.
1 device in this family has a Class I recall. 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? (5)
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 |
|---|---|---|---|
| * | K100042 | Difusion Technologies Xiphos Interbody Fusion SystemSummary page 1…Classification Name: Intervertebral Fusion Device with Bone Graft, Lumbar Regulation and Classification: 21 CER 888.3080, Class 11 Product Code:-MAX Predicate Devices K100042 - DiFusion Technologies XIPHOS IBF System K071 724 - Spinal Elements Lucent K072791 - Synthes Opal K071795 - Nuvasive Coroent K08… | 2010 |
| * | K071724 | LucentSummary page 1…e with Bone Graft, Lumbar Regulation and Classification: 21 CER 888.3080, Class 11 Product Code:-MAX Predicate Devices K100042 - DiFusion Technologies XIPHOS IBF System K071 724 - Spinal Elements Lucent K072791 - Synthes Opal K071795 - Nuvasive Coroent K080537 - Kiscomedica L-Varlock Device Description Th… | 2007 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 1…on and Classification: 21 CER 888.3080, Class 11 Product Code:-MAX Predicate Devices K100042 - DiFusion Technologies XIPHOS IBF System K071 724 - Spinal Elements Lucent K072791 - Synthes Opal K071795 - Nuvasive Coroent K080537 - Kiscomedica L-Varlock Device Description The BoneBacTM T-PLIF Intervertebral… | 2007 |
| * | K071795 | Nuvasive Coroent SystemSummary page 1…21 CER 888.3080, Class 11 Product Code:-MAX Predicate Devices K100042 - DiFusion Technologies XIPHOS IBF System K071 724 - Spinal Elements Lucent K072791 - Synthes Opal K071795 - Nuvasive Coroent K080537 - Kiscomedica L-Varlock Device Description The BoneBacTM T-PLIF Intervertebral Body Fusion Device is… | 2007 |
| * | K080537 | L-VarlockSummary page 1…roduct Code:-MAX Predicate Devices K100042 - DiFusion Technologies XIPHOS IBF System K071 724 - Spinal Elements Lucent K072791 - Synthes Opal K071795 - Nuvasive Coroent K080537 - Kiscomedica L-Varlock Device Description The BoneBacTM T-PLIF Intervertebral Body Fusion Device is a spinal intervertebral bod… | 2008 |
What descends from it? (762)
See all 7621 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120368 | Capstone Control Spinal System | 2012 | 761 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 33 ancestors have a recall of any class.
- Of its descendants, K120368 (Medtronic Sofamor Danek USA, Inc., 2012) has gone furthest, with 761 descendants of its own.
- 5 other devices also cite its predicate K100042.
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. 2011, 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 BoneBac M T-PLIF Intervertebral Body Fusion Device System is indicated for use in skeletally mature patients who have had six months of non-operative treatment. The device is intended for the treatment of degenerative disc disease (ODD) at one or two contiguous spinal levels from L2-S1. These DOD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). The BoneBacTM T-PLIF Intervertebral Body Fusion Device…
Read the full statement (115 words)
The BoneBac M T-PLIF Intervertebral Body Fusion Device System is indicated for use in skeletally mature patients who have had six months of non-operative treatment. The device is intended for the treatment of degenerative disc disease (ODD) at one or two contiguous spinal levels from L2-S1. These DOD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).
The BoneBacTM T-PLIF Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine and autogenous bone graft to facilitate fusion.
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111512: Bonebac T-Plif Intervertebral Body Fusion Device System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111512
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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