510(k) · Cleared
ClearedFlxfit Intervertebral Body Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Expanding Orthopedics, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 15, 2014 as substantially equivalent to K112095 (Coalign Innovations, Inc., 2011) and 5 other predicates after a 211-day review. Its family tree reaches back 14 generations to 1984. 137 later devices descend from it.
- Decided
- Jul 15, 2014
- Review
- 211 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K841189 (1984). 70 ancestors in all. 137 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 2 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 1 generation backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- This deviceK133813 Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc. · 2014
- Descendant · cites it directly · 72 of its ownK153400 ProLift Expandable SystemLife Spine, Inc. · 2016
- Descendant · cites it directly · 71 of its ownK171519 FLXfit™Expanding Orthopedics, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 55 of its ownK180078 Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 48 of its ownK183064 TxTi IBF SystemInnovasis, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 47 of its ownK201614 TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc. · 2020 · Recalled
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 4 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 3 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 2 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 1 generation backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- This deviceK133813 Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc. · 2014
Showing 5 of 137 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 137 · See all- K153400ProLift Expandable SystemLife Spine, Inc. · 2016 · cites it directly72descendants
- K171519FLXfit™Expanding Orthopedics, Inc. · 2017 · cites it directly71descendants
- K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc. · 2018 · 2 generations on55descendants
- K183064TxTi IBF SystemInnovasis, Inc. · 2019 · 3 generations on48descendants
- K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc. · 2020 · 4 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −4 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −3 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −2 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −1 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| 0 (this device) | K133813 | Flxfit Intervertebral Body Fusion Device | Expanding Orthopedics, Inc. | 2014 | — |
| +1 | K153400 | ProLift Expandable System | Life Spine, Inc. | 2016 | — |
| +1 | K171519 | FLXfit™ | Expanding Orthopedics, Inc. | 2017 | 1 |
| +2 | K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | Innovasis, Inc. | 2018 | 1 |
| +3 | K183064 | TxTi IBF System | Innovasis, Inc. | 2019 | 1 |
| +4 | K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | 2020 | 1 |
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 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 9 | 0 |
| 2019 | 9 | 0 |
| 2020 | 8 | 0 |
| 2021 | 12 | 0 |
| 2022 | 15 | 0 |
| 2023 | 14 | 0 |
| 2024 | 19 | 0 |
| 2025 | 26 | 0 |
| 2026 | 21 | 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? (6)
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 |
|---|---|---|---|
| * | K112095 | Acculif TL-Peek Ibf Cage | 2011 |
| * | K123281 | Acculif TL-Peek CageSummary page 1…tion Devices Panel 1Predicate Devices: CoAlign Innovation AccuLiF®)TL-PEEK Cage and AccuLiF®)TL and PL (KI 12095, K123281, and K 123752) Synthes T-PAL Spacer (K 100089)… | 2013 |
| * | K123752 | Acculif TL and PL CageSummary page 1…CoAlign Innovation AccuLiF®)TL-PEEK Cage and AccuLiF®)TL and PL (KI 12095, K123281, and K 123752) Synthes T-PAL Spacer (K 100089) II Custom Spine Pathway… | 2013 |
| * | K100089 | Synthes T-Pal SpacerSummary page 1…AccuLiF®)TL and PL (KI 12095, K123281, and K 123752) Synthes T-PAL Spacer (K 100089) II Custom Spine Pathway AVID (K090566) I L_ LKiscomedica L-Va… | 2010 |
| * | K090566 | Pathway AvidSummary page 1…K 123752) Synthes T-PAL Spacer (K 100089) II Custom Spine Pathway AVID (K090566) I L_ LKiscomedica L-Varlock (K080537) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICA… | 2009 |
| * | K080537 | L-VarlockSummary page 1…Synthes T-PAL Spacer (K 100089) II Custom Spine Pathway AVID (K090566) I L_ LKiscomedica L-Varlock (K080537) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: E01 ELXfit Intervertebral Body Fusion Device is made From Titani… | 2008 |
What descends from it? (137)
See all 1373 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 30 years and passes through 11 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 70 ancestors have a recall of any class.
- Of its descendants, K153400 (Life Spine, Inc., 2016) has gone furthest, with 72 descendants of its own.
- 10 other devices also cite its predicate K112095.
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. 2014, 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 E01 FLXfit Intervertebral body fusion device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmned by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The E01 FLXfit device is intended to be used with supplemental spinal fixation system and with autogenous bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133813: Flxfit 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/K133813
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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