510(k) · Cleared
ClearedUNiD Patient-matched PLIF 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 Jul 15, 2019 as substantially equivalent to K163595 (Medicrea International SA, 2017) and 1 other predicate after a 340-day review. Its family tree reaches back 19 generations to 1984. 1 of the 192 devices in its family, counting itself, has a Class I recall. 21 later devices descend from it.
- Decided
- Jul 15, 2019
- Review
- 340 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. 21 later devices descend from it, 3 citing it directly. 1 of the 192 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 deviceK182158 UNiD Patient-matched PLIF cageMedicrea International SA · 2019
- Descendant · cites it directly · 17 of its ownK202034 aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc. · 2020
- Descendant · 2 generations on · 12 of its ownK222009 aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2022
- 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 ownK241477 aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 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 deviceK182158 UNiD Patient-matched PLIF cageMedicrea International SA · 2019
Showing 5 of 21 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 21 · See all- K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc. · 2020 · cites it directly17descendants
- K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2022 · 2 generations on12descendants
- K210542aprevo Transforaminal IBFCarlsmed, Inc. · 2021 · cites it directly12descendants
- K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc. · 2022 · 2 generations on11descendants
- K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024 · 3 generations on6descendants
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) | K182158 | UNiD Patient-matched PLIF cage | Medicrea International SA | 2019 | — |
| +1 | K202034 | aprevo Intervertebral Body Fusion Device | Carlsmed, Inc. | 2020 | — |
| +2 | K222009 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2022 | — |
| +1 | K210542 | aprevo Transforaminal IBF | Carlsmed, Inc. | 2021 | — |
| +2 | K222082 | aprevo® anterior and lateral lumbar interbody fusion devices, aprevo®… | Carlsmed, Inc. | 2022 | — |
| +3 | K241477 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 8 | 0 |
| 2025 | 5 | 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…X Class II 3. Predicate or legally marketed devices which are substantially equivalent: Primary predicate: x MEDICREA INTERNATIONAL, IMPIX 3D printed cage (K163595) Additional predicate: x MEDICREA INTERNATIONAL, UNiD Patient Specific 3D Printed cage (K173782) 4. Description of the… | 2017 |
| * | K173782 | UNiD Patient Specific 3D printed cageSummary page 4…edicate: x MEDICREA INTERNATIONAL, IMPIX 3D printed cage (K163595) Additional predicate: x MEDICREA INTERNATIONAL, UNiD Patient Specific 3D Printed cage (K173782) 4. Description of the device: The UNiD patient-matched PLIF cage is an intervertebral lumbar device, designed to match the a… | 2018 |
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K202034 (Carlsmed, Inc., 2020) has gone furthest, with 17 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-matched PLIF cage is indicated for lumbar spinal fusion procedures in skeletally mature patients with
degenerative disc disease (DDD) at one or two contiguous levels form 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 bone graft.
UNiD Patient-matched PLIF 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182158: UNiD Patient-matched PLIF cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182158
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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