510(k) · Cleared
Recalled · Class II · 2023Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar Ibf
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea Technologies · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 19, 2010 as substantially equivalent to K072226 (Medicrea Technologies, 2007) after a 513-day review. Its family tree reaches back 2 generations to 1996. 32 later devices descend from it. It has been recalled 2 times.
- Decided
- May 19, 2010
- Review
- 513 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to P950002 (1996). 5 ancestors in all. 32 later devices descend from it, 3 citing it directly.
- Root · 2 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 1 generation backK072226 Impix SpacerMedicrea Technologies · 2007
- This deviceK083798 Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMedicrea Technologies · 2010
- Descendant · cites it directly · 28 of its ownK163595 IMPIX 3D Print CagesMedicrea International SA · 2017 · Recalled
- Descendant · 2 generations on · 23 of its ownK173782 UNiD Patient Specific 3D printed cageMedicrea International SA · 2018
- Descendant · 2 generations on · 21 of its ownK182158 UNiD Patient-matched PLIF cageMedicrea International SA · 2019
- Descendant · 3 generations on · 17 of its ownK202034 aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc. · 2020
- Descendant · 2 generations on · 13 of its ownK190092 UNiD Patient specific 3D printed TLIF cageMedicrea International SA · 2019
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K163595IMPIX 3D Print CagesMedicrea International SA · 2017 · cites it directly28descendants
- K173782UNiD Patient Specific 3D printed cageMedicrea International SA · 2018 · 2 generations on23descendants
- K182158UNiD Patient-matched PLIF cageMedicrea International SA · 2019 · 2 generations on21descendants
- K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc. · 2020 · 3 generations on17descendants
- K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA · 2019 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −1 | K072226 | Impix Spacer | Medicrea Technologies | 2007 | — |
| 0 (this device) | K083798 | Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar Ibf | Medicrea Technologies | 2010 | — |
| +1 | K163595 | IMPIX 3D Print Cages | Medicrea International SA | 2017 | 2 |
| +2 | K173782 | UNiD Patient Specific 3D printed cage | Medicrea International SA | 2018 | — |
| +2 | K182158 | UNiD Patient-matched PLIF cage | Medicrea International SA | 2019 | — |
| +3 | K202034 | aprevo Intervertebral Body Fusion Device | Carlsmed, Inc. | 2020 | — |
| +2 | K190092 | UNiD Patient specific 3D printed TLIF cage | Medicrea International SA | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 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.
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? (1)
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 |
|---|---|---|---|
| * | K072226 | Impix SpacerSummary page 1…tion 888.3080 Device panel Orthopedic Legally marketed IMPIX Lumbar Interbody Device, MAX (K072226) predicate devices Submitter MEDICREA Technologies ZI1. Che… | 2007 |
What descends from it? (32)
See all 323 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 |
|---|---|---|---|---|
| Jul 12, 2023 | Class II | Z-2457-2023 | 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. |
| Jul 12, 2023 | Class II | Z-2453-2023 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 11.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K163595 (Medicrea International SA, 2017) has gone furthest, with 28 descendants of its own.
- 10 other devices also cite its predicate K072226.
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. 2010, 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 Lumbar Interbody Device 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.
IMPIX Lumbar Interbody Device 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/K083798 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083798: Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar Ibf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083798
Report an extraction error
Are you the manufacturer?
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