510(k) · Cleared
Recalled · Class II · 2024Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 17, 2018 as substantially equivalent to K151785 (Innovasis, Inc., 2015) and 4 other predicates after a 97-day review. Its family tree reaches back 21 generations to 1984. 55 later devices descend from it. It has been recalled once.
- Decided
- Apr 17, 2018
- Review
- 97 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 21 generations to K841189 (1984). 212 ancestors in all. 55 later devices descend from it, 4 citing it directly.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 1 generation backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- This deviceK180078 Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc. · 2018
- Descendant · cites it directly · 48 of its ownK183064 TxTi IBF SystemInnovasis, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 47 of its ownK201614 TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 38 of its ownK211805 IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody…Alphatec Spine, Inc. · 2021
- Descendant · 4 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
- Descendant · 4 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 11 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 10 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 9 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 8 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 7 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 6 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 5 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 4 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 3 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 1 generation backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- This deviceK180078 Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc. · 2018
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K183064TxTi IBF SystemInnovasis, Inc. · 2019 · cites it directly48descendants
- K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc. · 2020 · 2 generations on47descendants
- K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc. · 2021 · 3 generations on38descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 4 generations on36descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 4 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −11 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −10 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −9 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −8 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −7 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −6 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −5 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −4 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −3 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −2 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| 0 (this device) | K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | Innovasis, Inc. | 2018 | — |
| +1 | K183064 | TxTi IBF System | Innovasis, Inc. | 2019 | 1 |
| +2 | K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | 2020 | 1 |
| +3 | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi… | Alphatec Spine, Inc. | 2021 | — |
| +4 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
| +4 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 13 | 0 |
| 2004 | 18 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 12 | 0 |
| 2008 | 29 | 0 |
| 2009 | 15 | 0 |
| 2010 | 12 | 0 |
| 2011 | 13 | 0 |
| 2012 | 7 | 0 |
| 2013 | 10 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 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? (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 |
|---|---|---|---|
| * | K151785 | Px HA PEEK IBF SystemSummary page 4…ertebral fusion device with bone graft Classification: Regulation No.: 21CFR 888.3080 Class 2 Product Code: MAX Review Panel: Orthopedic PSDB Primary Predicate Device: K151785 Innovasis Px HA® PEEK IBF System This predicate has not been subject to a design-related recall. Additional Predicates: Device… | 2015 |
| * | K143740 | Battalion Universal Spacer SystemSummary page 4…Predicate Device: K151785 Innovasis Px HA® PEEK IBF System This predicate has not been subject to a design-related recall. Additional Predicates: Device Description: K143740 K150500 K171633 K171519 Alphatec Battalion Universal Spacer System Innovasis Px PEEK IBF System NuVasive TLX Interbody System… | 2015 |
| * | K150500 | Px PEEK IBF SystemSummary page 4…te Device: K151785 Innovasis Px HA® PEEK IBF System This predicate has not been subject to a design-related recall. Additional Predicates: Device Description: K143740 K150500 K171633 K171519 Alphatec Battalion Universal Spacer System Innovasis Px PEEK IBF System NuVasive TLX Interbody System EOI FLXf… | 2015 |
| * | K171633 | NuVasive TLX Interbody SystemSummary page 4…e: K151785 Innovasis Px HA® PEEK IBF System This predicate has not been subject to a design-related recall. Additional Predicates: Device Description: K143740 K150500 K171633 K171519 Alphatec Battalion Universal Spacer System Innovasis Px PEEK IBF System NuVasive TLX Interbody System EOI FLXfit™ 15… | 2017 |
| * | K171519 | FLXfit™Summary page 4…85 Innovasis Px HA® PEEK IBF System This predicate has not been subject to a design-related recall. Additional Predicates: Device Description: K143740 K150500 K171633 K171519 Alphatec Battalion Universal Spacer System Innovasis Px PEEK IBF System NuVasive TLX Interbody System EOI FLXfit™ 15 The Inno… | 2017 |
What descends from it? (55)
See all 554 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2024 | Class II | Z-3163-2024 | Device Design | Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 22 of the 212 ancestors have a recall of any class.
- Of its descendants, K183064 (Innovasis, Inc., 2019) has gone furthest, with 48 descendants of its own.
- 1 other device also cites its predicate K151785.
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. 2018, 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 Innovasis PEEK IBF System (Px, Px HA and TxHA) is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these…
Read the full statement (158 words)
The Innovasis PEEK IBF System (Px, Px HA and TxHA) is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine. Px® and Px HA® devices are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach. TxHA™ devices are placed via a transforaminal (TLIF) approach.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.
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/K180078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180078: Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180078
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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