510(k) · Cleared
Recalled · Class II · 2023Impix Alif S/a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea International SA · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jan 15, 2015 as substantially equivalent to K101301 (Centinel Spine, 2010) and 4 other predicates after a 252-day review. Its family tree reaches back 12 generations to 1984. It has been recalled once.
- Decided
- Jan 15, 2015
- Review
- 252 days
- Class
- Class II
- Product code
- OVD
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 12 generations to K841189 (1984). 42 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 2 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 1 generation backK101301 Stalif MidlineCentinel Spine · 2010
- This deviceK141187 Impix Alif S/aMedicrea International SA · 2015
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 2 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 1 generation backK101301 Stalif MidlineCentinel Spine · 2010
- This deviceK141187 Impix Alif S/aMedicrea International SA · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −2 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −1 | K101301 | Stalif Midline | Centinel Spine | 2010 | — |
| 0 (this device) | K141187 | Impix Alif S/a | Medicrea International SA | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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 |
|---|---|---|---|
| * | K101301 | Stalif MidlineSummary page 4…ral Body Fusion Device Product Code: OVD; MAX 3. PREDICATE DEVICE The primary predicate used in this 510(k) notice is: x The STALIF MIDLINE (Centinel Spine, K101301) The additional predicates are: x The IMPIX ALIF Lumbar IBF (MEDICREA TECHNOLOGIE, K083798) x The IMPIX L (MEDICREA TECHN… | 2010 |
| * | K083798 | Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfSummary page 4…e used in this 510(k) notice is: x The STALIF MIDLINE (Centinel Spine, K101301) The additional predicates are: x The IMPIX ALIF Lumbar IBF (MEDICREA TECHNOLOGIE, K083798) x The IMPIX L (MEDICREA TECHNOLOGIE, K072226) x The SYNFIX LR (Synthes Spine, K062083) x The STALIF TT (Surgigraft L… | 2010 |
| * | K072226 | Impix SpacerSummary page 4…MIDLINE (Centinel Spine, K101301) The additional predicates are: x The IMPIX ALIF Lumbar IBF (MEDICREA TECHNOLOGIE, K083798) x The IMPIX L (MEDICREA TECHNOLOGIE, K072226) x The SYNFIX LR (Synthes Spine, K062083) x The STALIF TT (Surgigraft Limited,K073109) These predicates have not been s… | 2007 |
| * | K062083 | Synfix -LRSummary page 4…nal predicates are: x The IMPIX ALIF Lumbar IBF (MEDICREA TECHNOLOGIE, K083798) x The IMPIX L (MEDICREA TECHNOLOGIE, K072226) x The SYNFIX LR (Synthes Spine, K062083) x The STALIF TT (Surgigraft Limited,K073109) These predicates have not been subject to a design-related recall. === Page… | 2007 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 4…BF (MEDICREA TECHNOLOGIE, K083798) x The IMPIX L (MEDICREA TECHNOLOGIE, K072226) x The SYNFIX LR (Synthes Spine, K062083) x The STALIF TT (Surgigraft Limited,K073109) These predicates have not been subject to a design-related recall.… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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-2454-2023 | 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 31 years and passes through 11 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 42 ancestors have a recall of any class.
- 8 other devices also cite its predicate K101301.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The stand-alone intersomatic IMPIX ALIF S/A implants are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine 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…
Read the full statement (146 words)
The stand-alone intersomatic IMPIX ALIF S/A implants are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine 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.
Patients should have a satisfactory course of conservative treatment (usually at least six (6) months of non-operative treatment) prior to treatment with an IMPIX-ALIF-S/A stand-alone cage.
The IMPIX ALIF S/A devices should be used with the three (3) bone screws (Small Footprint) or four (4) bone screws (Medium, Large Footprints) accompanying the device. Otherwise, an additional fixation system (e.g., pedicle screw system) should be implanted.
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/K141187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141187: Impix Alif S/a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141187
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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