510(k) · Cleared
ClearedMectaLIF Anterior Stand-Alone
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 Jul 21, 2016 as substantially equivalent to K124034 (Medacta International, 2013) and 3 other predicates after a 141-day review. Its family tree reaches back 16 generations to 1984. 1 of the 142 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Jul 21, 2016
- Review
- 141 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K841189 (1984). 131 ancestors in all. 10 later devices descend from it, 7 citing it directly. 1 of the 142 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK131671 MectalifMedacta International · 2013
- 2 generations backK133192 Mectalif TipeekMedacta International · 2014
- 1 generation backK142744 Mecta-C TiPEEKMedacta International · 2015
- This deviceK160605 MectaLIF Anterior Stand-AloneMedacta International · 2016
- Descendant · cites it directly · 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
- Descendant · cites it directly · 1 of its ownK183426 MectaLIF Anterior Stand Alone ExtensionMedacta International S.A. · 2019
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 6 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 5 generations backK110927 MectalifMedacta International · 2011 · Recalled
- 4 generations backK120024 Mectalif TransforaminalMedacta International S.A. · 2012
- 3 generations backK131671 MectalifMedacta International · 2013
- 2 generations backK133192 Mectalif TipeekMedacta International · 2014
- 1 generation backK142744 Mecta-C TiPEEKMedacta International · 2015
- This deviceK160605 MectaLIF Anterior Stand-AloneMedacta International · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 5 of 10 · See all- K170455MectaLIF Anterior Stand AloneMedacta International S.A. · 2017 · cites it directly4descendants
- 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
- K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A. · 2019 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −6 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −5 | K110927 | Mectalif | Medacta International | 2011 | 1 |
| −4 | K120024 | Mectalif Transforaminal | Medacta International S.A. | 2012 | — |
| −3 | K131671 | Mectalif | Medacta International | 2013 | — |
| −2 | K133192 | Mectalif Tipeek | Medacta International | 2014 | — |
| −1 | K142744 | Mecta-C TiPEEK | Medacta International | 2015 | — |
| 0 (this device) | K160605 | MectaLIF Anterior Stand-Alone | Medacta International | 2016 | — |
| +1 | 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 | — |
| +1 | K183426 | MectaLIF Anterior Stand Alone Extension | Medacta International S.A. | 2019 | — |
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 | 9 | 0 |
| 2004 | 14 | 0 |
| 2005 | 14 | 0 |
| 2006 | 2 | 0 |
| 2007 | 8 | 0 |
| 2008 | 22 | 1 |
| 2009 | 10 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 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? (4)
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 |
|---|---|---|---|
| * | K124034 | Mectalif AnteriorSummary page 4…bar Product Code: OVD Regulation Number: 888.3080 Device Class: 2 PREDICATE DEVICE INFORMATION Primary Predicate: MectaLIF Anterior, K124034, Medacta International SA Additional Predicates: MectaLIF TiPEEK, K133192, Medacta International SA Mecta-C TiPEEK, K142744, Me… | 2013 |
| * | K133192 | Mectalif TipeekSummary page 4…e Class: 2 PREDICATE DEVICE INFORMATION Primary Predicate: MectaLIF Anterior, K124034, Medacta International SA Additional Predicates: MectaLIF TiPEEK, K133192, Medacta International SA Mecta-C TiPEEK, K142744, Medacta International SA Vu aPOD, K101310, Theken Spine MectaLIF Anterior S… | 2014 |
| * | K142744 | Mecta-C TiPEEKSummary page 4…ION Primary Predicate: MectaLIF Anterior, K124034, Medacta International SA Additional Predicates: MectaLIF TiPEEK, K133192, Medacta International SA Mecta-C TiPEEK, K142744, Medacta International SA Vu aPOD, K101310, Theken Spine MectaLIF Anterior Stand Alone K160605… | 2015 |
| * | K101310 | VU Apod Intervertebral Body Fusion DeviceSummary page 4…K124034, Medacta International SA Additional Predicates: MectaLIF TiPEEK, K133192, Medacta International SA Mecta-C TiPEEK, K142744, Medacta International SA Vu aPOD, K101310, Theken Spine MectaLIF Anterior Stand Alone K160605… | 2010 |
What descends from it? (10)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170455 | MectaLIF Anterior Stand Alone | 2017 | 4 |
| K221545 | MectaLIF Anterior Extension | 2022 | 2 |
| K192906 | Mecta-C Stand Alone | 2020 | 1 |
| K183426 | MectaLIF Anterior Stand Alone Extension | 2019 | 1 |
| K254202 | MectaLIF 3D Metal Anterior | 2026 | 0 |
| K250603 | AxTiHA® Stand-Alone ALIF System | 2025 | 0 |
| K200048 | MectaLIF Anterior Simple | 2020 | 0 |
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 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 11 companies; a new generation was cleared every 1.2 years on median.
- 21 of the 131 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170455 (Medacta International S.A., 2017) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K124034.
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. 2016, 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 Stand Alone system is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD 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 Stand Alone can be packed with autograft or autologous bone graft. DDD is defined as back…
Read the full statement (141 words)
The MectaLIF Anterior Stand Alone system is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD 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 Stand Alone can be packed with autograft or autologous bone graft.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The MectaLIF Anterior Stand-Alone system is a system intended to be used with bone screws provided and requires no additional supplementary fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160605 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160605: MectaLIF Anterior Stand-Alone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160605
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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