510(k) · Cleared
ClearedMectaLIF Anterior Simple
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 Mar 9, 2020 as substantially equivalent to K124034 (Medacta International, 2013) and 2 other predicates after a 60-day review. Its family tree reaches back 18 generations to 1984. 1 of the 134 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 9, 2020
- Review
- 60 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K841189 (1984). 133 ancestors in all. No later device cites it as a predicate yet. 1 of the 134 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK142744 Mecta-C TiPEEKMedacta International · 2015
- 2 generations backK160605 MectaLIF Anterior Stand-AloneMedacta International · 2016
- 1 generation backK170455 MectaLIF Anterior Stand AloneMedacta International S.A. · 2017
- This deviceK200048 MectaLIF Anterior SimpleMedacta International S.A. · 2020
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 8 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 7 generations backK110927 MectalifMedacta International · 2011 · Recalled
- 6 generations backK120024 Mectalif TransforaminalMedacta International S.A. · 2012
- 5 generations backK131671 MectalifMedacta International · 2013
- 4 generations backK133192 Mectalif TipeekMedacta International · 2014
- 3 generations backK142744 Mecta-C TiPEEKMedacta International · 2015
- 2 generations backK160605 MectaLIF Anterior Stand-AloneMedacta International · 2016
- 1 generation backK170455 MectaLIF Anterior Stand AloneMedacta International S.A. · 2017
- This deviceK200048 MectaLIF Anterior SimpleMedacta International S.A. · 2020
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 |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −8 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −7 | K110927 | Mectalif | Medacta International | 2011 | 1 |
| −6 | K120024 | Mectalif Transforaminal | Medacta International S.A. | 2012 | — |
| −5 | K131671 | Mectalif | Medacta International | 2013 | — |
| −4 | K133192 | Mectalif Tipeek | Medacta International | 2014 | — |
| −3 | K142744 | Mecta-C TiPEEK | Medacta International | 2015 | — |
| −2 | K160605 | MectaLIF Anterior Stand-Alone | Medacta International | 2016 | — |
| −1 | K170455 | MectaLIF Anterior Stand Alone | Medacta International S.A. | 2017 | — |
| 0 (this device) | K200048 | MectaLIF Anterior Simple | 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 | 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 |
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 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? (3)
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…ce Classification II III. Predicate Device Substantial equivalence is claimed to the following device: Primary Predicate: MectaLIF Anterior, K124034, Medacta International SA The following are additional predicate devices: MectaLIF Anterior Stand Alone, K160605, Me… | 2013 |
| * | K160605 | MectaLIF Anterior Stand-AloneSummary page 4… Primary Predicate: MectaLIF Anterior, K124034, Medacta International SA The following are additional predicate devices: MectaLIF Anterior Stand Alone, K160605, Medacta International SA MectaLIF Anterior Stand Alone, K170455, Medacta International SA IV. Device Descript… | 2016 |
| * | K170455 | MectaLIF Anterior Stand AloneSummary page 4…A The following are additional predicate devices: MectaLIF Anterior Stand Alone, K160605, Medacta International SA MectaLIF Anterior Stand Alone, K170455, Medacta International SA IV. Device Description The MectaLIF Anterior Simple devices are interbody fusion devices which… | 2017 |
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 36 years and passes through 11 companies; a new generation was cleared every 1.2 years on median.
- 21 of the 133 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K124034.
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. 2020, 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 Anterior 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 Mectal.IF Anterior System can be packed with autograft or autologous bone graft. DDD is defined as back pain of discogenic origin…
Read the full statement (156 words)
The MectalLIF Anterior 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 Mectal.IF Anterior System 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. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The MectalLIF Anterior Stand-Alone system is a system intended to be used with bone screws provided and requires no additional supplementary fixation. The MectalLIF 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/K200048 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200048: MectaLIF Anterior Simple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200048
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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