510(k) · Cleared
ClearedMectalif Anterior
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on May 17, 2013 as substantially equivalent to K101310 (Theken Spine, LLC, 2010) and 8 other predicates after a 140-day review. Its family tree reaches back 13 generations to 1984. 11 later devices descend from it.
- Decided
- May 17, 2013
- Review
- 140 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 13 generations to K841189 (1984). 90 ancestors in all. 11 later devices descend from it, 5 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 1 generation backK101310 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010
- This deviceK124034 Mectalif AnteriorMedacta International · 2013
- Descendant · cites it directly · 10 of its ownK160605 MectaLIF Anterior Stand-AloneMedacta International · 2016
- Descendant · 2 generations on · 4 of its ownK170455 MectaLIF Anterior Stand AloneMedacta International S.A. · 2017
- Descendant · cites it directly · 2 of its ownK221545 MectaLIF Anterior ExtensionMedacta International S.A. · 2022 · Recalled
- Descendant · 2 generations on · 1 of its ownK232123 MectaLIF Anterior Lag ExtensionMedacta International S.A. · 2023
- Descendant · cites it directly · 1 of its ownK192906 Mecta-C Stand AloneMedacta International S.A. · 2020
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 1 generation backK101310 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010
- This deviceK124034 Mectalif AnteriorMedacta International · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K160605MectaLIF Anterior Stand-AloneMedacta International · 2016 · cites it directly10descendants
- K170455MectaLIF Anterior Stand AloneMedacta International S.A. · 2017 · 2 generations on4descendants
- K221545MectaLIF Anterior ExtensionMedacta International S.A. · 2022 · cites it directly2descendants
- K232123MectaLIF Anterior Lag ExtensionMedacta International S.A. · 2023 · 2 generations on1descendant
- K192906Mecta-C Stand AloneMedacta International S.A. · 2020 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −3 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −2 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −1 | K101310 | VU Apod Intervertebral Body Fusion Device | Theken Spine, LLC | 2010 | — |
| 0 (this device) | K124034 | Mectalif Anterior | Medacta International | 2013 | — |
| +1 | K160605 | MectaLIF Anterior Stand-Alone | Medacta International | 2016 | — |
| +2 | K170455 | MectaLIF Anterior Stand Alone | Medacta International S.A. | 2017 | — |
| +1 | K221545 | MectaLIF Anterior Extension | Medacta International S.A. | 2022 | 6 |
| +2 | K232123 | MectaLIF Anterior Lag Extension | Medacta International S.A. | 2023 | — |
| +1 | K192906 | Mecta-C Stand Alone | Medacta International S.A. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 8 | 0 |
| 2004 | 11 | 0 |
| 2005 | 7 | 0 |
| 2007 | 7 | 0 |
| 2008 | 11 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (9)
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 |
|---|---|---|---|
| * | K101310 | VU Apod Intervertebral Body Fusion DeviceSummary page 1…21 CIFR 888.3080 Class 11 Device Product Codes: OVID Predicate Devices: K1 01310 Vu aPOD, Integra Spine K073109 Stalif TT, Centinel Spine K1 01 301 Stal Midline, Centinel Spine K1 10927 Mec… | 2010 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 1…Class 11 Device Product Codes: OVID Predicate Devices: K1 01310 Vu aPOD, Integra Spine K073109 Stalif TT, Centinel Spine K1 01 301 Stal Midline, Centinel Spine K1 10927 MectaLIF, Medacta International K0… | 2008 |
| * | K101301 | Stalif MidlineSummary page 1…1 Device Product Codes: OVID Predicate Devices: K1 01310 Vu aPOD, Integra Spine K073109 Stalif TT, Centinel Spine K1 01 301 Stal Midline, Centinel Spine K1 10927 MectaLIF, Medacta International K072253 SynFix-LR, Synthes K022791 ATB… | 2010 |
| * | K110927 | MectalifSummary page 1…duct Codes: OVID Predicate Devices: K1 01310 Vu aPOD, Integra Spine K073109 Stalif TT, Centinel Spine K1 01 301 Stal Midline, Centinel Spine K1 10927 MectaLIF, Medacta International K072253 SynFix-LR, Synthes K022791 ATB System, Synthes K071 726 Zuma, SeaSpi… | 2011 |
| * | K072253 | Synfix-LR SpacerSummary page 1…1310 Vu aPOD, Integra Spine K073109 Stalif TT, Centinel Spine K1 01 301 Stal Midline, Centinel Spine K1 10927 MectaLIF, Medacta International K072253 SynFix-LR, Synthes K022791 ATB System, Synthes K071 726 Zuma, SeaSpine K082252 Independence, Globus Medical… | 2007 |
| * | K022791 | Synthes Anterior Tension Band (Atb) SystemSummary page 1…K073109 Stalif TT, Centinel Spine K1 01 301 Stal Midline, Centinel Spine K1 10927 MectaLIF, Medacta International K072253 SynFix-LR, Synthes K022791 ATB System, Synthes K071 726 Zuma, SeaSpine K082252 Independence, Globus Medical K01 3665 Pyramid plate, Med… | 2002 |
| * | K071726 | ZUMASummary page 1…K1 01 301 Stal Midline, Centinel Spine K1 10927 MectaLIF, Medacta International K072253 SynFix-LR, Synthes K022791 ATB System, Synthes K071 726 Zuma, SeaSpine K082252 Independence, Globus Medical K01 3665 Pyramid plate, Medtronic MectaL-iF Anterior 510O(k)… | 2007 |
| * | K082252 | Independence SpacerSummary page 1…Centinel Spine K1 10927 MectaLIF, Medacta International K072253 SynFix-LR, Synthes K022791 ATB System, Synthes K071 726 Zuma, SeaSpine K082252 Independence, Globus Medical K01 3665 Pyramid plate, Medtronic MectaL-iF Anterior 510O(k)… | 2008 |
| * | K013665 | Pyramid Anterior Plate Fixation SystemSummary page 1…acta International K072253 SynFix-LR, Synthes K022791 ATB System, Synthes K071 726 Zuma, SeaSpine K082252 Independence, Globus Medical K01 3665 Pyramid plate, Medtronic MectaL-iF Anterior 510O(k) Section 5 - Page 2 of 4 === Page 2… | 2002 |
What descends from it? (11)
See all 115 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 15 of the 90 ancestors have a recall of any class.
- Of its descendants, K160605 (Medacta International, 2016) has gone furthest, with 10 descendants of its own.
- 10 other devices also cite its predicate K101310.
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. 2013, 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 MectaLIF Anterior is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DOD) at one or two contiguous levels from L2 to SI. These DIDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The interior of the spacer component of the MectaLIF Anterior can be packed with autograft or autologous bone graft. DD is defined as back pain of discogenic origin with…
Read the full statement (141 words)
The MectaLIF Anterior is an anterior interbody fusion device indicated for use in patients
with degenerative disc disease (DOD) at one or two contiguous levels from L2 to SI.
These DIDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at
the involved level(s). The interior of the spacer component of the MectaLIF Anterior can
be packed with autograft or autologous bone graft.
DD is defined as back pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies.
The MectaLIF Anterior is a system intended to be used with the integrated bone screws
provided and requires additional supplementary fixation such as pedicle screws and
rods.
These patients may have had a previous non-fusion spinal surgery at the involved
spinal level(s).
These patients should be skeletally mature and have had six months of non-operative
treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124034: Mectalif Anterior.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124034
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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