510(k) · Cleared
ClearedUNiD Patient specific 3D printed TLIF cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea International SA · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 8, 2019 as substantially equivalent to K163595 (Medicrea International SA, 2017) and 1 other predicate after a 110-day review. Its family tree reaches back 19 generations to 1984. 1 of the 184 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.
- Decided
- May 8, 2019
- Review
- 110 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K841189 (1984). 170 ancestors in all. 13 later devices descend from it, 1 citing it directly. 1 of the 184 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
- 2 generations backK163595 IMPIX 3D Print CagesMedicrea International SA · 2017 · Recalled
- 1 generation backK173782 UNiD Patient Specific 3D printed cageMedicrea International SA · 2018
- This deviceK190092 UNiD Patient specific 3D printed TLIF cageMedicrea International SA · 2019
- Descendant · cites it directly · 12 of its ownK210542 aprevo Transforaminal IBFCarlsmed, Inc. · 2021
- Descendant · 2 generations on · 11 of its ownK222082 aprevo® anterior and lateral lumbar interbody fusion devices…Carlsmed, Inc. · 2022
- Descendant · 3 generations on · 6 of its ownK231140 aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc. · 2023
- Descendant · 3 generations on · 5 of its ownK241332 aprevo® anterior and lateral lumbar interbody fusion device; aprevo®…Carlsmed, Inc. · 2024
- Descendant · 2 generations on · 4 of its ownK241019 aprevo® TLIF-C Articulating SystemCarlsmed · 2024
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 9 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 8 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 7 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 6 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 5 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 4 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 3 generations backK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
- 2 generations backK163595 IMPIX 3D Print CagesMedicrea International SA · 2017 · Recalled
- 1 generation backK173782 UNiD Patient Specific 3D printed cageMedicrea International SA · 2018
- This deviceK190092 UNiD Patient specific 3D printed TLIF cageMedicrea International SA · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 5 of 13 · See all- K210542aprevo Transforaminal IBFCarlsmed, Inc. · 2021 · cites it directly12descendants
- K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc. · 2022 · 2 generations on11descendants
- K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc. · 2023 · 3 generations on6descendants
- K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc. · 2024 · 3 generations on5descendants
- K241019aprevo® TLIF-C Articulating SystemCarlsmed · 2024 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −9 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −8 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −7 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −6 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −5 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −4 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −3 | K151214 | ALIF Interfixated System | Nu Vasive, Incorporated | 2015 | — |
| −2 | K163595 | IMPIX 3D Print Cages | Medicrea International SA | 2017 | 2 |
| −1 | K173782 | UNiD Patient Specific 3D printed cage | Medicrea International SA | 2018 | — |
| 0 (this device) | K190092 | UNiD Patient specific 3D printed TLIF cage | Medicrea International SA | 2019 | — |
| +1 | K210542 | aprevo Transforaminal IBF | Carlsmed, Inc. | 2021 | — |
| +2 | K222082 | aprevo® anterior and lateral lumbar interbody fusion devices, aprevo®… | Carlsmed, Inc. | 2022 | — |
| +3 | K231140 | aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. | 2023 | — |
| +3 | K241332 | aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior… | Carlsmed, Inc. | 2024 | — |
| +2 | K241019 | aprevo® TLIF-C Articulating System | Carlsmed | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 18 | 0 |
| 2005 | 15 | 0 |
| 2006 | 3 | 0 |
| 2007 | 11 | 0 |
| 2008 | 24 | 1 |
| 2009 | 10 | 0 |
| 2010 | 10 | 0 |
| 2011 | 9 | 0 |
| 2012 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K163595 | IMPIX 3D Print CagesSummary page 4…ass II 3. Predicate or legally marketed devices which are substantially equivalent: Primary predicate device: x IMPIX 3D printed cage, (MEDICREA INTERNATIONAL, K163595) Additional 3UHGLFDWH: x UNiD Patient specific 3D printed cage (MEDICREA INTERNATIONAL, K173782) 4. Description of the… | 2017 |
| * | K173782 | UNiD Patient Specific 3D printed cageSummary page 4…te device: x IMPIX 3D printed cage, (MEDICREA INTERNATIONAL, K163595) Additional 3UHGLFDWH: x UNiD Patient specific 3D printed cage (MEDICREA INTERNATIONAL, K173782) 4. Description of the device: MEDICREA® INTERNATIONAL UNiD Patient specific 3D Printed TLIF cage consists of one single implan… | 2018 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210542 | aprevo Transforaminal IBF | 2021 | 12 |
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 15 companies; a new generation was cleared every 1.0 years on median.
- 27 of the 170 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K210542 (Carlsmed, Inc., 2021) has gone furthest, with 12 descendants of its own.
- 4 other devices also cite its predicate K163595.
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. 2019, 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?
UNiD Patient specific 3D printed TLIF cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. 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). This device is…
Read the full statement (109 words)
UNiD Patient specific 3D printed TLIF cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. 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). This device is to be used with autogenous bone graft.
UNiD Patient specific 3D printed TLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190092 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190092: UNiD Patient specific 3D printed TLIF cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190092
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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