510(k) · Cleared
ClearedMectalif Tipeek
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 Jan 30, 2014 as substantially equivalent to K110927 (Medacta International, 2011) and 2 other predicates after a 105-day review. Its family tree reaches back 14 generations to 1984. 16 later devices descend from it.
- Decided
- Jan 30, 2014
- Review
- 105 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K841189 (1984). 70 ancestors in all. 16 later devices descend from it, 5 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK110927 MectalifMedacta International · 2011 · Recalled
- 2 generations backK120024 Mectalif TransforaminalMedacta International S.A. · 2012
- 1 generation backK131671 MectalifMedacta International · 2013
- This deviceK133192 Mectalif TipeekMedacta International · 2014
- Descendant · cites it directly · 12 of its ownK142744 Mecta-C TiPEEKMedacta International · 2015
- Descendant · cites it directly · 10 of its ownK160605 MectaLIF Anterior Stand-AloneMedacta International · 2016
- Descendant · 2 generations on · 4 of its ownK170455 MectaLIF Anterior Stand AloneMedacta International S.A. · 2017
- Descendant · 2 generations on · 2 of its ownK221545 MectaLIF Anterior ExtensionMedacta International S.A. · 2022 · Recalled
- Descendant · cites it directly · 2 of its ownK181970 MectaLIF Posterior ExtensionMedacta International S.A. · 2018
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 4 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 3 generations backK110927 MectalifMedacta International · 2011 · Recalled
- 2 generations backK120024 Mectalif TransforaminalMedacta International S.A. · 2012
- 1 generation backK131671 MectalifMedacta International · 2013
- This deviceK133192 Mectalif TipeekMedacta International · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K142744Mecta-C TiPEEKMedacta International · 2015 · cites it directly12descendants
- K160605MectaLIF Anterior Stand-AloneMedacta International · 2016 · cites it directly10descendants
- K170455MectaLIF Anterior Stand AloneMedacta International S.A. · 2017 · 2 generations on4descendants
- K221545MectaLIF Anterior ExtensionMedacta International S.A. · 2022 · 2 generations on2descendants
- K181970MectaLIF Posterior ExtensionMedacta International S.A. · 2018 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −4 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −3 | K110927 | Mectalif | Medacta International | 2011 | 1 |
| −2 | K120024 | Mectalif Transforaminal | Medacta International S.A. | 2012 | — |
| −1 | K131671 | Mectalif | Medacta International | 2013 | — |
| 0 (this device) | K133192 | Mectalif Tipeek | Medacta International | 2014 | — |
| +1 | K142744 | Mecta-C TiPEEK | Medacta International | 2015 | — |
| +1 | K160605 | MectaLIF Anterior Stand-Alone | Medacta International | 2016 | — |
| +2 | K170455 | MectaLIF Anterior Stand Alone | Medacta International S.A. | 2017 | — |
| +2 | K221545 | MectaLIF Anterior Extension | Medacta International S.A. | 2022 | 6 |
| +1 | K181970 | MectaLIF Posterior Extension | Medacta International S.A. | 2018 | — |
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 | 6 | 0 |
| 2004 | 8 | 0 |
| 2005 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K110927 | MectalifSummary page 1…raft, Lumbar 21 CFR 668.3080 Class 11 Device Product Codes: MAX Predicate Devices: 510(k) Product 510(k) Holder Dlaae K110927 MectaL-IF Medacta International 6/13/2011 K1 31671 MectalF Extension Me… | 2011 |
| * | K131671 | MectalifSummary page 1…510(k) Product 510(k) Holder Dlaae K110927 MectaL-IF Medacta International 6/13/2011 K1 31671 MectalF Extension Medacta International 7/05/2013 Ki112036 Calix PC Spinal Implant System X-s… | 2013 |
| * | K112036 | Calix PC Spinal Implant SystemSummary page 2…e implants cleared under K1 10927 and K1 31671 except for the addition of the commercially pure titanium (OPTi, ASTM F 1580) coating, which is the same coating used with K1 12036 Calix PC. The indications for use of MectaLIF TiPEEK are identical to the previously cleared predicate devices. The design featur… | 2011 |
What descends from it? (16)
See all 165 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 30 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 11 of the 70 ancestors have a recall of any class.
- Of its descendants, K142744 (Medacta International, 2015) has gone furthest, with 12 descendants of its own.
- 8 other devices also cite its predicate K110927.
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. 2014, 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 bane 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/K133192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133192: Mectalif Tipeek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133192
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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