510(k) · Cleared
ClearedMectaLIF 3D Metal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 17, 2025 as substantially equivalent to K212831 (Medacta International S.A., 2021) and 4 other predicates after a 106-day review. Its family tree reaches back 17 generations to 1984.
- Decided
- Jul 17, 2025
- Review
- 106 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K841189 (1984). 104 ancestors in all. No later device cites it as a predicate yet.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK133192 Mectalif TipeekMedacta International · 2014
- 2 generations backK181970 MectaLIF Posterior ExtensionMedacta International S.A. · 2018
- 1 generation backK212831 MectaLIF ExtensionMedacta International S.A. · 2021
- This deviceK251016 MectaLIF 3D MetalMedacta International S.A. · 2025
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 7 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 6 generations backK110927 MectalifMedacta International · 2011 · Recalled
- 5 generations backK120024 Mectalif TransforaminalMedacta International S.A. · 2012
- 4 generations backK131671 MectalifMedacta International · 2013
- 3 generations backK133192 Mectalif TipeekMedacta International · 2014
- 2 generations backK181970 MectaLIF Posterior ExtensionMedacta International S.A. · 2018
- 1 generation backK212831 MectaLIF ExtensionMedacta International S.A. · 2021
- This deviceK251016 MectaLIF 3D MetalMedacta International S.A. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −7 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −6 | K110927 | Mectalif | Medacta International | 2011 | 1 |
| −5 | K120024 | Mectalif Transforaminal | Medacta International S.A. | 2012 | — |
| −4 | K131671 | Mectalif | Medacta International | 2013 | — |
| −3 | K133192 | Mectalif Tipeek | Medacta International | 2014 | — |
| −2 | K181970 | MectaLIF Posterior Extension | Medacta International S.A. | 2018 | — |
| −1 | K212831 | MectaLIF Extension | Medacta International S.A. | 2021 | — |
| 0 (this device) | K251016 | MectaLIF 3D Metal | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 14 | 0 |
| 2005 | 11 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 8 | 0 |
| 2009 | 7 | 0 |
| 2010 | 2 | 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.
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? (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 |
|---|---|---|---|
| * | K212831 | MectaLIF ExtensionSummary page 5…n II III. Predicate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: x MectaLIF Extension, K212831, Medacta International SA Additional Predicate devices: x MectaLIF Posterior Extension, K181970, Medacta Interna… | 2021 |
| * | K181970 | MectaLIF Posterior ExtensionSummary page 5…Primary Predicate device: x MectaLIF Extension, K212831, Medacta International SA Additional Predicate devices: x MectaLIF Posterior Extension, K181970, Medacta International SA x MectaLIF TiPEEK, K133192, Medacta International SA x MectaLIF Extension, K131671, M… | 2018 |
| * | K133192 | Mectalif TipeekSummary page 5…31, Medacta International SA Additional Predicate devices: x MectaLIF Posterior Extension, K181970, Medacta International SA x MectaLIF TiPEEK, K133192, Medacta International SA x MectaLIF Extension, K131671, Medacta International SA x MectaLIF, K110927, Medacta… | 2014 |
| * | K131671 | MectalifSummary page 5…: x MectaLIF Posterior Extension, K181970, Medacta International SA x MectaLIF TiPEEK, K133192, Medacta International SA x MectaLIF Extension, K131671, Medacta International SA x MectaLIF, K110927, Medacta International SA Reference devices: x Mpact 3D M… | 2013 |
| * | K110927 | MectalifSummary page 5…acta International SA x MectaLIF TiPEEK, K133192, Medacta International SA x MectaLIF Extension, K131671, Medacta International SA x MectaLIF, K110927, Medacta International SA Reference devices: x Mpact 3D Metal Implants – DMLS Technology, K202568, Medacta Inter… | 2011 |
| † | K202568 | Mpact® 3D Metal Implants - DMLS Technology | 2021 |
| † | K221850 | GMK 3D Metal Tibial Tray | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 41 years and passes through 11 companies; a new generation was cleared every 1.3 years on median.
- 14 of the 104 ancestors have a recall of any class.
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. 2025, 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?
The MectalLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 — S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.
These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
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/K251016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251016: MectaLIF 3D Metal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251016
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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