510(k) · Cleared
Recalled · Class II · 2023IMPIX 3D Print Cages
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 Nov 13, 2017 as substantially equivalent to K150481 (K2m, Inc., 2015) and 4 other predicates after a 327-day review. Its family tree reaches back 17 generations to 1984. 1 of the 197 devices in its family, counting itself, has a Class I recall. 28 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 13, 2017
- Review
- 327 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 17 generations to K841189 (1984). 168 ancestors in all. 28 later devices descend from it, 5 citing it directly. 1 of the 197 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 2 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 1 generation backK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
- This deviceK163595 IMPIX 3D Print CagesMedicrea International SA · 2017
- Descendant · cites it directly · 23 of its ownK173782 UNiD Patient Specific 3D printed cageMedicrea International SA · 2018
- Descendant · cites it directly · 21 of its ownK182158 UNiD Patient-matched PLIF cageMedicrea International SA · 2019
- Descendant · 2 generations on · 17 of its ownK202034 aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc. · 2020
- Descendant · cites it directly · 13 of its ownK190092 UNiD Patient specific 3D printed TLIF cageMedicrea International SA · 2019
- Descendant · 3 generations on · 12 of its ownK222009 aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2022
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 7 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 6 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 5 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 4 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 3 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 2 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 1 generation backK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
- This deviceK163595 IMPIX 3D Print CagesMedicrea International SA · 2017
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 28 · See all- K173782UNiD Patient Specific 3D printed cageMedicrea International SA · 2018 · cites it directly23descendants
- K182158UNiD Patient-matched PLIF cageMedicrea International SA · 2019 · cites it directly21descendants
- K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc. · 2020 · 2 generations on17descendants
- K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA · 2019 · cites it directly13descendants
- K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2022 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −7 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −6 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −5 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −4 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −3 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −2 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −1 | K151214 | ALIF Interfixated System | Nu Vasive, Incorporated | 2015 | — |
| 0 (this device) | K163595 | IMPIX 3D Print Cages | Medicrea International SA | 2017 | — |
| +1 | K173782 | UNiD Patient Specific 3D printed cage | Medicrea International SA | 2018 | — |
| +1 | K182158 | UNiD Patient-matched PLIF cage | Medicrea International SA | 2019 | — |
| +2 | K202034 | aprevo Intervertebral Body Fusion Device | Carlsmed, Inc. | 2020 | — |
| +1 | K190092 | UNiD Patient specific 3D printed TLIF cage | Medicrea International SA | 2019 | — |
| +3 | K222009 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2022 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 9 | 0 |
| 2025 | 6 | 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? (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 |
|---|---|---|---|
| * | K150481 | Cascadia Interbody SystemSummary page 4…Code: MAX Class II 3. Predicate or legally marketed devices which are substantially equivalent: Primary predicate: x K2M Cascadia Interbody System (K150481) Additional predicate: x MEDICREA INTERNATIONAL IMPIX-L (K072226) x CAPSTONE® Spinal System (K121760) x MEDICREA IM… | 2015 |
| * | K072226 | Impix SpacerSummary page 4…s which are substantially equivalent: Primary predicate: x K2M Cascadia Interbody System (K150481) Additional predicate: x MEDICREA INTERNATIONAL IMPIX-L (K072226) x CAPSTONE® Spinal System (K121760) x MEDICREA IMPIX ALIF (K083798) x NUVASIVE INTERFIXED SYSTEM (K151214) No refer… | 2007 |
| * | K121760 | Capstone Spinal SystemSummary page 4…Primary predicate: x K2M Cascadia Interbody System (K150481) Additional predicate: x MEDICREA INTERNATIONAL IMPIX-L (K072226) x CAPSTONE® Spinal System (K121760) x MEDICREA IMPIX ALIF (K083798) x NUVASIVE INTERFIXED SYSTEM (K151214) No reference devices were used in this submissi… | 2012 |
| * | K083798 | Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfSummary page 4…adia Interbody System (K150481) Additional predicate: x MEDICREA INTERNATIONAL IMPIX-L (K072226) x CAPSTONE® Spinal System (K121760) x MEDICREA IMPIX ALIF (K083798) x NUVASIVE INTERFIXED SYSTEM (K151214) No reference devices were used in this submission… | 2010 |
| * | K151214 | ALIF Interfixated SystemSummary page 4…ional predicate: x MEDICREA INTERNATIONAL IMPIX-L (K072226) x CAPSTONE® Spinal System (K121760) x MEDICREA IMPIX ALIF (K083798) x NUVASIVE INTERFIXED SYSTEM (K151214) No reference devices were used in this submission… | 2015 |
What descends from it? (28)
See all 285 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2023 | Class II | Z-2452-2023 | Under Investigation by firm | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| Oct 2, 2019 | Class II | Z-1156-2020 | Process control | Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter |
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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 15 companies; a new generation was cleared every 1.0 years on median.
- 26 of the 168 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K173782 (Medicrea International SA, 2018) has gone furthest, with 23 descendants of its own.
- 15 other devices also cite its predicate K150481.
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. 2017, 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?
IMPIX 3D Print cages are 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.
IMPIX 3D Print cages are 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/K163595 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163595: IMPIX 3D Print Cages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163595
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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