510(k) · Cleared
ClearedMectaLIF 3D Metal Anterior
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on May 5, 2026 as substantially equivalent to K232123 (Medacta International S.A., 2023) and 4 other predicates after a 127-day review. Its family tree reaches back 20 generations to 1984. 1 of the 141 devices in its family, counting itself, has a Class I recall.
- Decided
- May 5, 2026
- Review
- 127 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 20 generations to K841189 (1984). 140 ancestors in all. No later device cites it as a predicate yet. 1 of the 141 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK170455 MectaLIF Anterior Stand AloneMedacta International S.A. · 2017
- 2 generations backK221545 MectaLIF Anterior ExtensionMedacta International S.A. · 2022 · Recalled
- 1 generation backK232123 MectaLIF Anterior Lag ExtensionMedacta International S.A. · 2023
- This deviceK254202 MectaLIF 3D Metal AnteriorMedacta International S.A. · 2026
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 10 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 9 generations backK110927 MectalifMedacta International · 2011 · Recalled
- 8 generations backK120024 Mectalif TransforaminalMedacta International S.A. · 2012
- 7 generations backK131671 MectalifMedacta International · 2013
- 6 generations backK133192 Mectalif TipeekMedacta International · 2014
- 5 generations backK142744 Mecta-C TiPEEKMedacta International · 2015
- 4 generations backK160605 MectaLIF Anterior Stand-AloneMedacta International · 2016
- 3 generations backK170455 MectaLIF Anterior Stand AloneMedacta International S.A. · 2017
- 2 generations backK221545 MectaLIF Anterior ExtensionMedacta International S.A. · 2022 · Recalled
- 1 generation backK232123 MectaLIF Anterior Lag ExtensionMedacta International S.A. · 2023
- This deviceK254202 MectaLIF 3D Metal AnteriorMedacta International S.A. · 2026
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −10 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −9 | K110927 | Mectalif | Medacta International | 2011 | 1 |
| −8 | K120024 | Mectalif Transforaminal | Medacta International S.A. | 2012 | — |
| −7 | K131671 | Mectalif | Medacta International | 2013 | — |
| −6 | K133192 | Mectalif Tipeek | Medacta International | 2014 | — |
| −5 | K142744 | Mecta-C TiPEEK | Medacta International | 2015 | — |
| −4 | K160605 | MectaLIF Anterior Stand-Alone | Medacta International | 2016 | — |
| −3 | K170455 | MectaLIF Anterior Stand Alone | Medacta International S.A. | 2017 | — |
| −2 | K221545 | MectaLIF Anterior Extension | Medacta International S.A. | 2022 | 6 |
| −1 | K232123 | MectaLIF Anterior Lag Extension | Medacta International S.A. | 2023 | — |
| 0 (this device) | K254202 | MectaLIF 3D Metal Anterior | Medacta International S.A. | 2026 | — |
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 | 15 | 0 |
| 2006 | 2 | 0 |
| 2007 | 8 | 0 |
| 2008 | 24 | 1 |
| 2009 | 11 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K232123 | MectaLIF Anterior Lag ExtensionSummary page 6…III. Predicate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: • MectaLIF Anterior Lag Extension, K232123, Medacta International SA Additional Predicate devices: • MectaLIF Anterior, K124034, Medacta International SA… | 2023 |
| * | K124034 | Mectalif AnteriorSummary page 6…Primary Predicate device: • MectaLIF Anterior Lag Extension, K232123, Medacta International SA Additional Predicate devices: • MectaLIF Anterior, K124034, Medacta International SA • MectaLIF Anterior Stand Alone, K160605, Medacta International SA • MectaLIF Anterio… | 2013 |
| * | K160605 | MectaLIF Anterior Stand-AloneSummary page 6…Medacta International SA Additional Predicate devices: • MectaLIF Anterior, K124034, Medacta International SA • MectaLIF Anterior Stand Alone, K160605, Medacta International SA • MectaLIF Anterior Stand Alone, K170455, Medacta International SA • MectaLIF Anterio… | 2016 |
| * | K170455 | MectaLIF Anterior Stand AloneSummary page 6…ectaLIF Anterior, K124034, Medacta International SA • MectaLIF Anterior Stand Alone, K160605, Medacta International SA • MectaLIF Anterior Stand Alone, K170455, Medacta International SA • MectaLIF Anterior Extension, K221545, Medacta International SA Reference devices:… | 2017 |
| * | K221545 | MectaLIF Anterior ExtensionSummary page 6…terior Stand Alone, K160605, Medacta International SA • MectaLIF Anterior Stand Alone, K170455, Medacta International SA • MectaLIF Anterior Extension, K221545, Medacta International SA Reference devices: • MectaLIF 3D Metal, K251016, Medacta International SA === Page 7… | 2022 |
| † | K251016 | MectaLIF 3D Metal | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 11 companies; a new generation was cleared every 1.2 years on median.
- 23 of the 140 ancestors have a recall of any class; 1 has a Class I recall.
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. 2026, 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 3D Metal Anterior is an 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 3D Metal Anterior should be packed with autograft or autologous bone graft. DDD is defined as back pain of discogenic…
Read the full statement (317 words)
The MectaLIF 3D Metal Anterior is an 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 3D Metal Anterior should 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 at least six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The MectaLIF 3D Metal Anterior Stand-Alone system is intended to be used with bone screws provided and requires no additional supplementary fixation.
MectaLIF 3D Metal Anterior with a lordotic angle greater than 20° will require additional supplemental fixation such as pedicle screws and rods.
The MectaLIF Anterior is an 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 should 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 at least six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The MectaLIF Anterior Stand-Alone system is intended to be used with bone screws provided and requires no additional supplementary fixation.
The MectaLIF Anterior Simple requires additional supplementary fixation such as pedicle screws and rods or lumbar anterior plate system.
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/K254202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254202: MectaLIF 3D Metal Anterior.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254202
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026