510(k) · Cleared
Recalled · Class II · 2014Mectalif
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 13, 2011 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 5 other predicates after a 77-day review. Its family tree reaches back 11 generations to 1984. 30 later devices descend from it. It has been recalled once.
- Decided
- Jun 13, 2011
- Review
- 77 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 11 generations to K841189 (1984). 49 ancestors in all. 30 later devices descend from it, 9 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 1 generation backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- This deviceK110927 MectalifMedacta International · 2011
- Descendant · cites it directly · 23 of its ownK120024 Mectalif TransforaminalMedacta International S.A. · 2012
- Descendant · cites it directly · 22 of its ownK131671 MectalifMedacta International · 2013
- Descendant · cites it directly · 16 of its ownK133192 Mectalif TipeekMedacta International · 2014
- Descendant · cites it directly · 14 of its ownK112862 Mecta-CMedacta International · 2011
- Descendant · 2 generations on · 12 of its ownK142744 Mecta-C TiPEEKMedacta International · 2015
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 1 generation backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- This deviceK110927 MectalifMedacta International · 2011
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K120024Mectalif TransforaminalMedacta International S.A. · 2012 · cites it directly23descendants
- K131671MectalifMedacta International · 2013 · cites it directly22descendants
- K133192Mectalif TipeekMedacta International · 2014 · cites it directly16descendants
- K112862Mecta-CMedacta International · 2011 · cites it directly14descendants
- K142744Mecta-C TiPEEKMedacta International · 2015 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −1 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| 0 (this device) | K110927 | Mectalif | Medacta International | 2011 | — |
| +1 | K120024 | Mectalif Transforaminal | Medacta International S.A. | 2012 | — |
| +1 | K131671 | Mectalif | Medacta International | 2013 | — |
| +1 | K133192 | Mectalif Tipeek | Medacta International | 2014 | — |
| +1 | K112862 | Mecta-C | Medacta International | 2011 | — |
| +2 | K142744 | Mecta-C TiPEEK | Medacta International | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2025 | 3 | 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.
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? (6)
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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…21 CFR 888.3080 Class 11 Device Product Codes: MAX Predicate Devices: P960025 Lumbar I/F Cage K072791 Opal Spacer K081917 Devex and Leopard Systems K0… | 1999 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 1…3080 Class 11 Device Product Codes: MAX Predicate Devices: P960025 Lumbar I/F Cage K072791 Opal Spacer K081917 Devex and Leopard Systems K073291 Capstone Spinal System… | 2007 |
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 1…lass 11 Device Product Codes: MAX Predicate Devices: P960025 Lumbar I/F Cage K072791 Opal Spacer K081917 Devex and Leopard Systems K073291 Capstone Spinal System K040536 Verte-Stack Boomerang… | 2009 |
| * | K073291 | Capstone Spinal SystemSummary page 1…ct Codes: MAX Predicate Devices: P960025 Lumbar I/F Cage K072791 Opal Spacer K081917 Devex and Leopard Systems K073291 Capstone Spinal System K040536 Verte-Stack Boomerang K1 001 75 Clydesdale Spinal System… | 2008 |
| * | K040536 | Modification to Verte-Stack Spinal SystemSummary page 1…I/F Cage K072791 Opal Spacer K081917 Devex and Leopard Systems K073291 Capstone Spinal System K040536 Verte-Stack Boomerang K1 001 75 Clydesdale Spinal System MectaLIF 510(k)… | 2004 |
| * | K100175 | Clydesdale Spinal SystemSummary page 1…K081917 Devex and Leopard Systems K073291 Capstone Spinal System K040536 Verte-Stack Boomerang K1 001 75 Clydesdale Spinal System MectaLIF 510(k) Section 5 - Page 2 of 4 === Page 2 =… | 2010 |
What descends from it? (30)
See all 309 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120024 | Mectalif Transforaminal | 2012 | 23 |
| K131671 | Mectalif | 2013 | 22 |
| K133192 | Mectalif Tipeek | 2014 | 16 |
| K112862 | Mecta-C | 2011 | 14 |
| K124034 | Mectalif Anterior | 2013 | 11 |
| K192026 | Peridot Intervertebral body fusion System | 2019 | 6 |
| K181970 | MectaLIF Posterior Extension | 2018 | 2 |
| K212831 | MectaLIF Extension | 2021 | 1 |
| K251016 | MectaLIF 3D Metal | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2014 | Class II | Z-0225-2015 | Employee error | The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 5 of the 49 ancestors have a recall of any class.
- Of its descendants, K120024 (Medacta International S.A., 2012) has gone furthest, with 23 descendants of its own.
- 98 other devices also cite its predicate P960025.
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. 2011, 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 MectaLiF 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 - Si 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 as stated in the FDA summary.
https://510kreport.com/device/K110927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110927: Mectalif.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110927
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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