510(k) · Cleared
Cleared3D Printed PEEK Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nvision Biomedical Technologies, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 17, 2024 as substantially equivalent to K193645 (Nvision Biomedical Technologies, Inc., 2020) and 2 other predicates after a 231-day review. Its family tree reaches back 18 generations to 2001.
- Decided
- Sep 17, 2024
- Review
- 231 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K003155 (2001). 223 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations between
- 3 generations backK151496 Latitude-C Cervical Interbody Spacer SystemDegen Medical · 2015
- 2 generations backK181261 Curiteva Cervical Interbody Fusion SystemCuriteva, LLC · 2018
- 1 generation backK213030 Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2023
- This deviceK240250 3D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc. · 2024
Show all 18 generations
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 17 generations backK012254 VBROsteotech, Inc. · 2001
- 16 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 15 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 13 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 12 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 11 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 10 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 9 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 8 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 7 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 6 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 5 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 4 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 3 generations backK151496 Latitude-C Cervical Interbody Spacer SystemDegen Medical · 2015
- 2 generations backK181261 Curiteva Cervical Interbody Fusion SystemCuriteva, LLC · 2018
- 1 generation backK213030 Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2023
- This deviceK240250 3D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −17 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −16 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −15 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −13 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −12 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −11 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −10 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −9 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −8 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −7 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −6 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −5 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| −4 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| −3 | K151496 | Latitude-C Cervical Interbody Spacer System | Degen Medical | 2015 | — |
| −2 | K181261 | Curiteva Cervical Interbody Fusion System | Curiteva, LLC | 2018 | — |
| −1 | K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2023 | — |
| 0 (this device) | K240250 | 3D Printed PEEK Interbody System | Nvision Biomedical Technologies, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 25 | 0 |
| 2005 | 15 | 0 |
| 2006 | 7 | 0 |
| 2007 | 13 | 0 |
| 2008 | 28 | 0 |
| 2009 | 16 | 0 |
| 2010 | 7 | 0 |
| 2011 | 11 | 0 |
| 2012 | 7 | 0 |
| 2013 | 9 | 0 |
| 2014 | 11 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K193645 | nva, nvp, and nvtSummary page 5…ES The subject device is substantially equivalent to the following predicates: 510(k) # Manufacturer & Predicate Device Name Predicate K193645 Nvision Biomedical Technologies nva, nvp, and nvt (MAX) Primary Predicate K190380 Nvision Biomedical Technolog… | 2020 |
| * | K190380 | nvcSummary page 5…anufacturer & Predicate Device Name Predicate K193645 Nvision Biomedical Technologies nva, nvp, and nvt (MAX) Primary Predicate K190380 Nvision Biomedical Technologies nvc (ODP) Additional Predicate K213030 Curiteva Porous PEEK Cerv… | 2019 |
| * | K213030 | Curiteva Porous PEEK Cervical Interbody Fusion SystemSummary page 5…edical Technologies nva, nvp, and nvt (MAX) Primary Predicate K190380 Nvision Biomedical Technologies nvc (ODP) Additional Predicate K213030 Curiteva Porous PEEK Cervical Interbody Fusion System (ODP) Additional Predicate… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 12 companies; a new generation was cleared every 11 months on median.
- 27 of the 223 ancestors have a recall of any class.
- 2 other devices also cite its predicate K193645.
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. 2024, 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 3D Printed PEEK Interbody System (ALIF) is intended for spinal fusion procedures in the lumbosacral spine at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an…
Read the full statement (266 words)
The 3D Printed PEEK Interbody System (ALIF) is intended for spinal fusion procedures in the lumbosacral spine at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral body fusion device. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device must be used with supplemental fixation and is intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The device is to be implanted via an anterior approach.
The 3D Printed PEEK Interbody System (Cervical) is intended for spinal fusion procedures in the cervical spine at one or two contiguous levels from C2 to T1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device must be used with supplemental fixation and is intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The device is to be implanted via an anterior approach.
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/K240250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240250: 3D Printed PEEK Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240250
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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