510(k) · Cleared
ClearedMectaLIF Extension
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 Oct 29, 2021 as substantially equivalent to K133192 (Medacta International, 2014) and 4 other predicates after a 52-day review. Its family tree reaches back 16 generations to 1984. 1 later device descends from it.
- Decided
- Oct 29, 2021
- Review
- 52 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K841189 (1984). 103 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK181970 MectaLIF Posterior ExtensionMedacta International S.A. · 2018
- This deviceK212831 MectaLIF ExtensionMedacta International S.A. · 2021
- Descendant · cites it directly · 0 of its ownK251016 MectaLIF 3D MetalMedacta International S.A. · 2025
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 backK181970 MectaLIF Posterior ExtensionMedacta International S.A. · 2018
- This deviceK212831 MectaLIF ExtensionMedacta International S.A. · 2021
Most influential descendants
Showing 1 of 1 · See all- K251016MectaLIF 3D MetalMedacta International S.A. · 2025 · cites it directly0descendants
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 | K181970 | MectaLIF Posterior Extension | Medacta International S.A. | 2018 | — |
| 0 (this device) | K212831 | MectaLIF Extension | Medacta International S.A. | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K133192 | Mectalif TipeekSummary page 4…R 888.3080 Device Classification II III. Predicate Device Substantial equivalence is claimed to the following primary predicate device: MectaLIF TiPEEK, K133192, Medacta International SA In addition, the following additional predicate devices are cited within the submission: Aleutia… | 2014 |
| * | K130699 | Aleutian Spinal SystemSummary page 4… MectaLIF TiPEEK, K133192, Medacta International SA In addition, the following additional predicate devices are cited within the submission: Aleutian IBF System, K130699, K2M, Inc. MectaLIF, K110927, Medacta International SA MectaLIF Extension, K131671, Medacta International SA Me… | 2013 |
| * | K110927 | MectalifSummary page 4…International SA In addition, the following additional predicate devices are cited within the submission: Aleutian IBF System, K130699, K2M, Inc. MectaLIF, K110927, Medacta International SA MectaLIF Extension, K131671, Medacta International SA MectaLIF Posterior Extension, K181970… | 2011 |
| * | K131671 | MectalifSummary page 4…dicate devices are cited within the submission: Aleutian IBF System, K130699, K2M, Inc. MectaLIF, K110927, Medacta International SA MectaLIF Extension, K131671, Medacta International SA MectaLIF Posterior Extension, K181970, Medacta International SA IV. Device Description The s… | 2013 |
| * | K181970 | MectaLIF Posterior ExtensionSummary page 4…tem, K130699, K2M, Inc. MectaLIF, K110927, Medacta International SA MectaLIF Extension, K131671, Medacta International SA MectaLIF Posterior Extension, K181970, Medacta International SA IV. Device Description The subject MectaLIF Extension implants are a line extension to the MectaLI… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251016 | MectaLIF 3D Metal | 2025 | 0 |
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 37 years and passes through 11 companies; a new generation was cleared every 1.3 years on median.
- 14 of the 103 ancestors have a recall of any class.
- Of its descendants, K251016 (Medacta International S.A., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K133192.
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. 2021, 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/K212831 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212831: MectaLIF Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212831
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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